New · posted Nov 14
Generate Biomedicines · Biotechnology
Associate Director, Clinical Data Management
- Somerville, MA
- On-site
- Full-time
- Director
The role
The Associate Director, Clinical Data Management will serve as the lead data manager for one or more clinical programs, providing strategic and operational oversight of study-level data management activities from study start-up through database lock. This role is ideal for an experienced hands-on data management professional who enjoys partnering closely with cross-functional teams and CROs to ensure the delivery of high-quality clinical data.
The successful candidate will be responsible for study execution, vendor oversight, risk identification, and data quality management while serving as the primary data management representative for assigned clinical studies.
Study-Level Data Management Leadership
· Serve as the lead data manager for assigned phase 3 clinical studies and programs.
· Develop and maintain study-specific data management strategies, timelines, and deliverables.
· Provide oversight of CRO and vendor data management activities to ensure quality, compliance, and adherence to timelines.
· Review and approve key data management documents, including Data Management Plans (DMPs), Data Validation Plans (DVPs), edit check specifications, eCRF specifications, and database build documentation.
· Lead data review, query management, reconciliation, and database lock activities.
Study Oversight & Cross-Functional Collaboration
· Partner with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Pharmacovigilance, and external vendors throughout study conduct.
· Monitor data quality and study metrics to proactively identify risks and drive issue resolution.
· Support external data integrations and reconciliation activities.
· Participate in study team meetings and provide regular updates on data management activities, risks, and timelines.
· Contribute to inspection readiness and ensure compliance with GCP and applicable regulatory requirements.
Vendor Management
· Act as the primary point of contact for CRO and vendor data management activities.
· Review vendor deliverables and ensure study requirements are met.
· Escalate study risks, issues, and timeline concerns as appropriate.
· Drive accountability for study-level data management deliverables.
Process Improvement
· Contribute to the development and improvement of data management processes and standards.
· Share best practices and lessons learned across studies.
· Support initiatives to improve data quality, efficiency, and study execution.
Compensation: The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.
What you need
The Ideal Candidate will havenice to have
· Bachelor's degree in Life Sciences, Health Sciences, Computer Science, or a related discipline.
· Minimum of 10+ years of clinical data management experience within the pharmaceutical, biotechnology, or CRO industry.
· Experience serving as a lead data manager for Phase 2 and/or Phase 3 clinical trials.
· Strong hands-on experience with Medidata Rave EDC.
· Experience managing CRO and vendor deliverables.
· Solid understanding of database design, edit checks, data review, query management, and reconciliation activities.
· Strong knowledge of ICH-GCP and applicable regulatory requirements.
· Excellent written, verbal, and interpersonal communication skills.
· Strong organizational skills with the ability to manage multiple priorities and timelines.
Preferrednice to have
· Experience in COPD, respiratory, pulmonary, or related therapeutic areas.
· Experience working in a small to mid-sized biotechnology company environment.
· Experience supporting global Phase 3 clinical studies.
· Familiarity with CDISC standards and risk-based data review methodologies.
· Experience with external vendor data integrations and reconciliations.
Key Competencies
· Strong study execution and project management skills.
· Excellent communication and stakeholder management abilities.
· Ability to influence without direct authority.
· Proactive problem-solving and risk management mindset.
· Detail-oriented with a focus on data quality and operational excellence.
· Comfortable working independently in a fast-paced biotech environment.
Pay and benefits
$162,000 – $205,000 a year
Employer providedAnnual bonus
Equity compensation
Competitive benefits package
Where you'll work
Somerville, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Somerville, MAFrom the posting
About Generate Biomedicines
We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation, this approach aims to reduce the uncertainty, time, and cost associated with developing protein-based medicines.
Founded in 2018, we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model, we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation.
At Generate:Biomedicines, we collaborate across disciplines in new ways to invent and innovate. We bring diverse perspectives to a shared goal of delivering better medicines to patients in need, faster, guided by our values and leadership behaviors.
Per Year Salary Range
$162,000—$205,000 USD
Equal opportunity, accessibility and legal noticesGenerate Biomedicines's statements, word for word
Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.
Job intelligence
The context around this role
Live data · November 14, 2026
Salary intelligence
How the pay compares
This role's midpoint is 15% below the US median for Clinical Data Management roles at this level.
This roleEmployer provided
Director roles in Massachusetts5 roles publishing pay
Director roles in the US14 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $162,000 | — | $205,000 |
| Massachusetts (middle half) | $178,500 | $234,500 | $244,000 |
| All US (middle half) | $180,125 | $215,000 | $241,625 |
This role: Generate Biomedicines's own published range. Comparisons: the base pay employers published on open Clinical Data Management roles at the same level on Regulatory Jobs, November 14, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Data Management
The general path across 62 open Clinical Data Management roles on Regulatory Jobs, with the titles they carry most. Not Generate Biomedicines's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 40 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Data and digital systems11
- Clinical trial conduct11
- Collaboration and leadership8
- Documentation and SOPs4
- GMP and compliance3
- Lab testing and methods1
- Validation and qualification1
- Quality systems and risk1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Data Management work in biotechnology, led by the two this posting names, each linked to the agency or standards body that publishes it.
- CDISCCDISC standards(official source, opens in a new tab)SDTM, ADaM and CDASH, the clinical data standards FDA and PMDA requireNamed in the posting
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- FDAFDA study data standards(official source, opens in a new tab)Required data standards and technical conformance for clinical study data
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ICHMedDRA(official source, opens in a new tab)The ICH medical terminology for coding adverse events and medical history
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- ICHICH E3(official source, opens in a new tab)Structure and content of clinical study reports
Company hiring pulse
Generate Biomedicines on Regulatory Jobs
- 5
- Open roles
- 5
- Distinct roles
- 3
- Locations
By discipline
- Clinical4 80%
- Quality1 20%
By level
- Director4 80%
- Manager1 20%
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Associate Director, Clinical Data Management at Generate Biomedicines
Open until filled. $162K–$205K a year, employer provided.