Associate Director Clinical Data Management Jobs
Associate Director Clinical Data Management jobs are open across pharmaceutical, biotechnology, medical device, and CRO industries, from senior manager to executive level, with specializations in oncology trials, regulatory submissions, and data standards such as CDISC. Find a role that fits from the openings below and apply directly.
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About Us
Nkarta is a publicly traded (Nasdaq symbol NKTX), clinical-stage biotechnology company headquartered in South San Francisco, focused on advancing the development of allogeneic, off-the-shelf natural killer (NK) cell therapies to treat autoimmune disease.
Founded in 2015, Nkarta is on a mission to harness the body's natural killer cells – the immune system's first responders – to deliver a safe, accessible form of cell therapy to treat B cell-mediated autoimmune diseases. Our vision is to make cell therapy more broadly available to patients by pioneering allogeneic NK cells that can be dosed in outpatient, community health settings.
Nkarta's engineering process enhances the natural ability of NK cells to fight disease by identifying and eliminating unhealthy cells, including malfunctioning B cells at the root of many autoimmune conditions. Our lead NK cell therapy candidate, NKX019, uses NK cells collected from healthy donors rather than burdening the patient with a blood collection. Using donor-derived cells allows us to develop CAR NK cells off the shelf and on demand.
Nkarta is a people-driven company looking for passionate, collaborative, determined team members galvanized by a paradigm-shifting opportunity to change the cell therapy landscape.
THE OPPORTUNITY
Nkarta is seeking a Senior Director or Executive Director to serve as Head of Clinical Data Management (CDM). This is a hands-on leadership role for an experienced data management executive who will own the strategy, operating model, and quality of clinical data across the NKX019 autoimmune program—from ongoing multi-indication Phase 1/2 studies through potential future pivotal trials and a Biologics License Application (BLA).
NKX019 is being studied in multiple autoimmune indications under rapidly evolving protocols. The Head of CDM will ensure every protocol change is reflected promptly and correctly in the database, that data are analysis-ready for frequent data cuts, and that the function is built to deliver a submission-quality database for future pivotal studies.
Reporting to the VP, Program Management and Head of Clinical Trial Services, this leader will direct Nkarta's internal data managers and contract staff, hold the biometrics CRO and data vendors accountable for quality and timelines, and partner closely with Clinical Development, Clinical Operations, Biostatistics, Drug Safety, Medical Writing and Regulatory Affairs.
WHAT YOU'LL DO
Strategic Direction & Functional Leadership
- Serve as Head of Clinical Data Management and set the vision, strategy and operating model for CDM across all Nkarta clinical studies.
- Establish portfolio-wide clinical data governance covering data ownership, standards, system interoperability and decision rights across internal functions and external partners.
- Build a CDM function that scales from the current Phase 1/2 portfolio to future pivotal studies and BLA readiness, with the right balance of in-house, contract and CRO resources.
- Define and execute a pivotal-readiness roadmap before study initiation, encompassing data standards, system architecture, vendor capabilities, resourcing, quality controls and inspection-ready documentation.
- Align CDM plans, resources and timelines with corporate objectives and study milestones; flag risks early with recommendations.
- Represent CDM on program teams and in leadership forums, and drive cross-functional data strategy with Clinical Development, Biostatistics, Clinical Operations, Regulatory Affairs, Drug Safety, Translational Medicine and Medical Writing so that data are clinically meaningful, traceable and fit for analysis and regulatory use.
Study Data Delivery & Database Lock
- Participate in protocol development and amendment review to ensure that what the protocol requires can be collected, cleaned and analyzed; drive CRF and electronic data capture (EDC) design accordingly.
- Own EDC change control for protocol amendments—specifications, edit checks, user acceptance testing (UAT), migration and release—delivered on time without loss of data integrity.
- Develop and maintain data management plans covering data collection, processing, medical coding, reconciliation (including SAE and central laboratory data), review and storage.
- Own the end-to-end strategy for external data flows, including transfer specifications and agreements, ingestion validation, traceability, reconciliation, exception handling and timely availability of laboratory, imaging, biomarker, safety and cell-product data.
- Plan and deliver clean data snapshots and locked databases, as appropriate, for interim analyses, safety and data monitoring committee reviews, congress presentations, regulatory submissions and study close-out.
- Lead cross-functional data review with Clinical Development, Biostatistics and Drug Safety; direct discrepancy and query management and resolve data issues at their root.
- Establish risk-based data quality oversight that identifies trends in delayed entry, unresolved queries and recurring vendor or site issues; lead root-cause analysis and corrective actions.
Vendor Oversight & Budget
- Provide sponsor oversight of the biometrics CRO, data management contractors and other data vendors: define scope, key performance indicators, sponsor acceptance criteria and escalation pathways; review deliverables against specification; and drive remediation of performance issues.
- Lead selection, auditing and onboarding of CDM and Biometrics vendors, including vendor strategy for pivotal and global studies.
- Oversee the quality and integrity of clinical trial data from third-party vendors (e.g., CROs, central and specialty labs, eCOA/ePRO, imaging, IRT), reviewing vendor data for accuracy, completeness and timeliness and resolving discrepancies. Own CDM resource planning, budget forecasting and change-order review.
Quality, Compliance & Inspection Readiness
- Lead the creation and continuous improvement of CDM Global Standard Operating Procedures (GSOPs), work instructions and standards aligned with CDISC (CDASH/SDTM), Good Clinical Practice (GCP), Good Clinical Data Management Practices (GCDMP), 21 CFR Part 11, applicable data privacy requirements and International Council for Harmonisation (ICH) E6 guidelines.
- Maintain complete, current, inspection-ready CDM documentation in the Trial Master File—eCRF specifications and completion guidelines, annotated CRFs, data validation specifications, data transfer agreements, data management plans and change-control logs—with traceable evidence that data management controls operated effectively.
- Prepare the CDM function and its vendors for BLA submission, regulatory inspection and audit; lead CDM responses to audit findings and quality events.
People Leadership
- Recruit, develop and lead CDM employees and consultants; set clear expectations, coach for growth, and create a team culture of accountability and data quality.
- At either level, own portfolio-wide data strategy, governance and pivotal readiness; at Executive Director level, take on broader scope, including portfolio-wide data standards, systems and analytics, ex-US CDM strategy, and greater organizational leadership and enterprise influence.
WHAT WE'RE LOOKING FOR
Required
- BS/BA and/or MS degree in a science- or health-related field, or an equivalent combination of education and experience.
- 12+ years of clinical data management experience in the pharmaceutical or biotechnology industry (15+ years for Executive Director), including 5+ years leading a CDM function or CDM for a major program.
- Demonstrated leadership of data management through database lock for a pivotal (Phase 3 or registrational) study, and CDM contribution to at least one marketing application (BLA, NDA or MAA).
- Deep knowledge of CDM processes, EDC systems (including Medidata Rave), database build and change control, data validation, external data reconciliation, MedDRA and WHODrug coding, quality management and current CDM technology.
- Strong knowledge of GCP, CDISC standards (including CDASH and SDTM), FDA and ICH guidelines, and CDM best practices.
- Proven sponsor-side oversight of CROs and data vendors, including scope, budget and performance management.
- Demonstrated success building or transforming a sponsor-side CDM operating model in a resource-lean biotechnology organization, including rapid amendments, multi-indication studies and frequent interim data cuts.
- Demonstrated line-management experience, with the ability to lead and inspire CDM employees, consultants and external partners.
- Outstanding problem-solving, influencing, negotiation and communication skills; strong attention to detail; and the ability to manage multiple priorities in a fast-paced, resource-lean environment.
Preferred
- Experience in immunology or rheumatology, cell therapy, gene therapy or other complex biologics.
- Experience with complex composite and responder endpoints, patient-reported outcomes and external data sources (central laboratory, imaging, cell-product and biomarker data).
- Experience preparing a CDM function for a first BLA and regulatory inspection in a small or mid-sized company.
- Experience supporting global (US and EU) clinical studies.
LOCATION & WORK ENVIRONMENT
Priority will be given to candidates who can work a hybrid schedule and based in South San Francisco, CA. Travel may be required for health-authority meetings, conferences, vendor oversight, and other business needs.
Working at Nkarta
There are several factors taken into consideration in determining base salary, including but not limited to: job-related qualifications, skills, education and experience, as well as the value of other elements of an employee's total compensation package. Nkarta also offers an annual discretionary bonus, equity grant(s), medical, dental, vision and life insurance coverage, in accordance with the terms and conditions of the applicable plans. Other benefits include 401K plan, flexible spending account, ESPP, employee assistance program, paid vacation, holiday and personal days, paid parental, pregnancy, and bereavement leave.
The 100+ team members describe working at Nkarta through some of the following comments. While getting better work-life balance and improving communications between groups in an early stage start up environment are two areas on which we are working, here are real, anonymous comments about or regarding why people think Nkarta is a great place to work.
- "People are always open to ideas."
- "Exceptionally talented, committed, *kind* & supportive team."
- "The CEO is transparent and honest with expectations for the whole company. There is genuine care amongst the leadership team for their peers and employees. I believe this is unique."
- "Not to sound corny, but the emphasis on people as a valuable resource is something I recognize doesn't often exist elsewhere, and it's here in ample supply, which is great."
- "It's the first place that I've worked where the executive team truly values the employees. It's a pretty amazing thing not to hear that employees can be replaced with someone new. Institutional knowledge is understood."
- "We have a very diverse team with executives that are friendly and accessible."
- "Smart and dedicated colleagues. Mission to make a difference in patients' lives. Empower us with tools needed to succeed. Open and transparent culture. Transparent leadership."
To learn more about our work at Nkarta and the career opportunities that will drive us forward to serve patients, please visit the company's website at https://www.nkartatx.com.
About Us
Nkarta is a publicly traded (Nasdaq symbol NKTX), clinical-stage biotechnology company headquartered in South San Francisco, focused on advancing the development of allogeneic, off-the-shelf natural killer (NK) cell therapies to treat autoimmune disease.
Founded in 2015, Nkarta is on a mission to harness the body's natural killer cells – the immune system's first responders – to deliver a safe, accessible form of cell therapy to treat B cell-mediated autoimmune diseases. Our vision is to make cell therapy more broadly available to patients by pioneering allogeneic NK cells that can be dosed in outpatient, community health settings.
Nkarta's engineering process enhances the natural ability of NK cells to fight disease by identifying and eliminating unhealthy cells, including malfunctioning B cells at the root of many autoimmune conditions. Our lead NK cell therapy candidate, NKX019, uses NK cells collected from healthy donors rather than burdening the patient with a blood collection. Using donor-derived cells allows us to develop CAR NK cells off the shelf and on demand.
Nkarta is a people-driven company looking for passionate, collaborative, determined team members galvanized by a paradigm-shifting opportunity to change the cell therapy landscape.
THE OPPORTUNITY
Nkarta is seeking a Senior Director or Executive Director to serve as Head of Clinical Data Management (CDM). This is a hands-on leadership role for an experienced data management executive who will own the strategy, operating model, and quality of clinical data across the NKX019 autoimmune program—from ongoing multi-indication Phase 1/2 studies through potential future pivotal trials and a Biologics License Application (BLA).
NKX019 is being studied in multiple autoimmune indications under rapidly evolving protocols. The Head of CDM will ensure every protocol change is reflected promptly and correctly in the database, that data are analysis-ready for frequent data cuts, and that the function is built to deliver a submission-quality database for future pivotal studies.
Reporting to the VP, Program Management and Head of Clinical Trial Services, this leader will direct Nkarta's internal data managers and contract staff, hold the biometrics CRO and data vendors accountable for quality and timelines, and partner closely with Clinical Development, Clinical Operations, Biostatistics, Drug Safety, Medical Writing and Regulatory Affairs.
WHAT YOU'LL DO
Strategic Direction & Functional Leadership
- Serve as Head of Clinical Data Management and set the vision, strategy and operating model for CDM across all Nkarta clinical studies.
- Establish portfolio-wide clinical data governance covering data ownership, standards, system interoperability and decision rights across internal functions and external partners.
- Build a CDM function that scales from the current Phase 1/2 portfolio to future pivotal studies and BLA readiness, with the right balance of in-house, contract and CRO resources.
- Define and execute a pivotal-readiness roadmap before study initiation, encompassing data standards, system architecture, vendor capabilities, resourcing, quality controls and inspection-ready documentation.
- Align CDM plans, resources and timelines with corporate objectives and study milestones; flag risks early with recommendations.
- Represent CDM on program teams and in leadership forums, and drive cross-functional data strategy with Clinical Development, Biostatistics, Clinical Operations, Regulatory Affairs, Drug Safety, Translational Medicine and Medical Writing so that data are clinically meaningful, traceable and fit for analysis and regulatory use.
Study Data Delivery & Database Lock
- Participate in protocol development and amendment review to ensure that what the protocol requires can be collected, cleaned and analyzed; drive CRF and electronic data capture (EDC) design accordingly.
- Own EDC change control for protocol amendments—specifications, edit checks, user acceptance testing (UAT), migration and release—delivered on time without loss of data integrity.
- Develop and maintain data management plans covering data collection, processing, medical coding, reconciliation (including SAE and central laboratory data), review and storage.
- Own the end-to-end strategy for external data flows, including transfer specifications and agreements, ingestion validation, traceability, reconciliation, exception handling and timely availability of laboratory, imaging, biomarker, safety and cell-product data.
- Plan and deliver clean data snapshots and locked databases, as appropriate, for interim analyses, safety and data monitoring committee reviews, congress presentations, regulatory submissions and study close-out.
- Lead cross-functional data review with Clinical Development, Biostatistics and Drug Safety; direct discrepancy and query management and resolve data issues at their root.
- Establish risk-based data quality oversight that identifies trends in delayed entry, unresolved queries and recurring vendor or site issues; lead root-cause analysis and corrective actions.
Vendor Oversight & Budget
- Provide sponsor oversight of the biometrics CRO, data management contractors and other data vendors: define scope, key performance indicators, sponsor acceptance criteria and escalation pathways; review deliverables against specification; and drive remediation of performance issues.
- Lead selection, auditing and onboarding of CDM and Biometrics vendors, including vendor strategy for pivotal and global studies.
- Oversee the quality and integrity of clinical trial data from third-party vendors (e.g., CROs, central and specialty labs, eCOA/ePRO, imaging, IRT), reviewing vendor data for accuracy, completeness and timeliness and resolving discrepancies. Own CDM resource planning, budget forecasting and change-order review.
Quality, Compliance & Inspection Readiness
- Lead the creation and continuous improvement of CDM Global Standard Operating Procedures (GSOPs), work instructions and standards aligned with CDISC (CDASH/SDTM), Good Clinical Practice (GCP), Good Clinical Data Management Practices (GCDMP), 21 CFR Part 11, applicable data privacy requirements and International Council for Harmonisation (ICH) E6 guidelines.
- Maintain complete, current, inspection-ready CDM documentation in the Trial Master File—eCRF specifications and completion guidelines, annotated CRFs, data validation specifications, data transfer agreements, data management plans and change-control logs—with traceable evidence that data management controls operated effectively.
- Prepare the CDM function and its vendors for BLA submission, regulatory inspection and audit; lead CDM responses to audit findings and quality events.
People Leadership
- Recruit, develop and lead CDM employees and consultants; set clear expectations, coach for growth, and create a team culture of accountability and data quality.
- At either level, own portfolio-wide data strategy, governance and pivotal readiness; at Executive Director level, take on broader scope, including portfolio-wide data standards, systems and analytics, ex-US CDM strategy, and greater organizational leadership and enterprise influence.
WHAT WE'RE LOOKING FOR
Required
- BS/BA and/or MS degree in a science- or health-related field, or an equivalent combination of education and experience.
- 12+ years of clinical data management experience in the pharmaceutical or biotechnology industry (15+ years for Executive Director), including 5+ years leading a CDM function or CDM for a major program.
- Demonstrated leadership of data management through database lock for a pivotal (Phase 3 or registrational) study, and CDM contribution to at least one marketing application (BLA, NDA or MAA).
- Deep knowledge of CDM processes, EDC systems (including Medidata Rave), database build and change control, data validation, external data reconciliation, MedDRA and WHODrug coding, quality management and current CDM technology.
- Strong knowledge of GCP, CDISC standards (including CDASH and SDTM), FDA and ICH guidelines, and CDM best practices.
- Proven sponsor-side oversight of CROs and data vendors, including scope, budget and performance management.
- Demonstrated success building or transforming a sponsor-side CDM operating model in a resource-lean biotechnology organization, including rapid amendments, multi-indication studies and frequent interim data cuts.
- Demonstrated line-management experience, with the ability to lead and inspire CDM employees, consultants and external partners.
- Outstanding problem-solving, influencing, negotiation and communication skills; strong attention to detail; and the ability to manage multiple priorities in a fast-paced, resource-lean environment.
Preferred
- Experience in immunology or rheumatology, cell therapy, gene therapy or other complex biologics.
- Experience with complex composite and responder endpoints, patient-reported outcomes and external data sources (central laboratory, imaging, cell-product and biomarker data).
- Experience preparing a CDM function for a first BLA and regulatory inspection in a small or mid-sized company.
- Experience supporting global (US and EU) clinical studies.
LOCATION & WORK ENVIRONMENT
Priority will be given to candidates who can work a hybrid schedule and based in South San Francisco, CA. Travel may be required for health-authority meetings, conferences, vendor oversight, and other business needs.
Working at Nkarta
There are several factors taken into consideration in determining base salary, including but not limited to: job-related qualifications, skills, education and experience, as well as the value of other elements of an employee's total compensation package. Nkarta also offers an annual discretionary bonus, equity grant(s), medical, dental, vision and life insurance coverage, in accordance with the terms and conditions of the applicable plans. Other benefits include 401K plan, flexible spending account, ESPP, employee assistance program, paid vacation, holiday and personal days, paid parental, pregnancy, and bereavement leave.
The 100+ team members describe working at Nkarta through some of the following comments. While getting better work-life balance and improving communications between groups in an early stage start up environment are two areas on which we are working, here are real, anonymous comments about or regarding why people think Nkarta is a great place to work.
- "People are always open to ideas."
- "Exceptionally talented, committed, *kind* & supportive team."
- "The CEO is transparent and honest with expectations for the whole company. There is genuine care amongst the leadership team for their peers and employees. I believe this is unique."
- "Not to sound corny, but the emphasis on people as a valuable resource is something I recognize doesn't often exist elsewhere, and it's here in ample supply, which is great."
- "It's the first place that I've worked where the executive team truly values the employees. It's a pretty amazing thing not to hear that employees can be replaced with someone new. Institutional knowledge is understood."
- "We have a very diverse team with executives that are friendly and accessible."
- "Smart and dedicated colleagues. Mission to make a difference in patients' lives. Empower us with tools needed to succeed. Open and transparent culture. Transparent leadership."
To learn more about our work at Nkarta and the career opportunities that will drive us forward to serve patients, please visit the company's website at https://www.nkartatx.com.
Associate Director Clinical Data Management Jobs by Experience Level
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Find JobsAssociate Director Clinical Data Management Job Market
Who's Hiring
Top Industries Hiring
- Biotechnology & Pharmaceuticals
- Healthcare & Medical Services
What Employers Look For
The qualifications that appear most often in associate director clinical data management jobs.
- Bachelor's or advanced degree in life sciences, statistics, or a related field
- Minimum seven to ten years of clinical data management experience in pharma or biotech
- Hands-on experience with EDC systems such as Medidata Rave, Oracle InForm, or Veeva Vault
- Proficiency in CDISC standards including CDASH, SDTM, and ADaM
- Demonstrated experience leading and mentoring clinical data management teams
- Knowledge of ICH E6 Good Clinical Practice guidelines and 21 CFR Part 11 compliance
Tips for Your Associate Director Clinical Data Management Job Search
Quantify your data management wins
Hiring managers at this level want to see scale and impact. Cite the number of studies you oversaw simultaneously, the size of teams you led, and how your process improvements reduced database lock timelines or query resolution rates.
Highlight CDISC and 21 CFR Part 11 fluency
Most job postings at this level explicitly require CDASH, SDTM, and ADaM expertise alongside regulatory compliance knowledge. If your resume buries these under a generic skills section, move them to a prominent summary line so they clear applicant tracking systems immediately.
Target postings by phase and therapeutic area
Oncology, rare disease, and late-phase trials each have distinct data management complexity. Filter openings by the therapeutic area where your strongest study experience sits so your application speaks directly to the complexity the team is already managing.
Apply early to roles that fit
Migrate Mate lists associate director clinical data management openings from across the United States in one place, so you can find roles that match and apply directly to each listing.
Prepare for a technical panel interview
Expect a multi-round process where at least one session includes clinical data managers or bioinformatics leads who will probe your EDC platform choices, your SAS or R validation practices, and how you handle protocol amendments mid-study. Prepare concrete examples for each area.
Negotiate scope, not just compensation
At the associate director level, the breadth of your portfolio, access to cross-functional leadership, and whether you own vendor oversight or just execution all shape your trajectory. Clarify those boundaries during the offer stage before accepting.
Associate Director Clinical Data Management Jobs: Frequently Asked Questions
Which companies are hiring the most associate director clinical data managements?
The companies hiring the most associate director clinical data managements right now include PTC Therapeutics, Revolution Medicines, and Merck, with the largest share of openings in New Jersey, California, and Massachusetts, based on current listings on Migrate Mate as of November 2026. Large CROs and mid-size biopharmaceutical companies tend to post the highest volume of roles at this level.
How many associate director clinical data management jobs are remote?
About 57% of associate director clinical data management openings are fully remote or hybrid as of November 2026, reflecting the function's historically strong remote infrastructure. Roles focused on data standards oversight, vendor management, and regulatory submission support tend to be the most amenable to fully remote arrangements compared to site-facing or hands-on EDC build positions.
How do you become an associate director clinical data management?
You typically progress into this role by first building several years of hands-on experience as a clinical data manager or senior clinical data manager, then moving into a lead or principal role where you manage cross-functional study teams. Deepening your expertise in CDISC standards, EDC platforms, and regulatory compliance, combined with demonstrated team leadership, positions you for the associate director step.
Can you get hired as an associate director clinical data management without direct leadership experience?
Most employers expect at least some formal or informal team leadership before hiring at the associate director level, but relevant depth can compensate for limited direct reports. Candidates who have led cross-functional study teams, served as a subject matter expert on CDISC implementation projects, or managed external data vendors often compete effectively even without a traditional management title on their resume.
What does the associate director clinical data management interview process look like?
The process typically runs three to four rounds, starting with a recruiter screen focused on background and level fit, followed by a hiring manager conversation about leadership philosophy and therapeutic area experience. A technical panel with clinical data managers or biostatistics colleagues then probes EDC choices, CDISC implementation decisions, and regulatory compliance scenarios. A final round with senior leadership or cross-functional stakeholders usually closes the process.
Where can I find and apply to associate director clinical data management jobs?
You can find and apply to associate director clinical data management jobs on Migrate Mate, which lists current openings from employers across the United States. Search the available roles, find the ones that match your experience and target therapeutic area, and apply directly to each listing from the page.
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