Associate Director, Clinical Data Management

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.

Here's how you will contribute:

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.

The Ideal Candidate will 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.

Preferred

· 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.

 

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.

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.

 

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