Senior Manager, Clinical Data Management

The Role: 

The Senior Manager, Clinical Data Management will serve as the lead data manager for one or more clinical studies or programs, providing strategic and operational oversight of study-level data management activities from study start-up through database lock. This is a hands-on role for an experienced clinical data management professional who can independently drive execution, partner effectively with cross-functional teams and CROs, and maintain high data quality in a fast-paced environment.

The successful candidate will be responsible for study execution, vendor oversight, database build testing activities, risk identification, data review, and data quality management. The role requires sound judgment, strong communication, accountability, and the ability to remain effective while managing competing priorities, changing requirements, and time-sensitive deliverables.

Here's how you will contribute:

• Serve as the lead data manager for assigned clinical studies and programs, developing and maintaining study-specific data management strategies, timelines, and deliverables.

• Review and approve key data management documents, including Data Management Plans, Data Validation Plans, edit check specifications, eCRF specifications, and database build documentation.

• Provide hands-on oversight of Medidata Rave EDC database builds, including eCRFs, edit checks, custom functions, workflows, and related configuration; create, run, review, and interpret Rave reports and listings to support data review, cleaning, reconciliation, and oversight.

• Plan, perform, and document testing of database builds, edit checks, eCRFs, derivations, and system functionality; identify defects, assess impact, track resolution, and verify fixes through UAT.

• Lead data review, query management, external data reconciliation, and database lock activities, including oversight of CRO and vendor deliverables.

• Monitor data quality, review metrics and study timelines to identify risks early, and support external data integrations, transfer specifications, reconciliation activities, and inspection readiness.

• Partner with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Pharmacovigilance, and external vendors throughout study conduct; provide clear, timely updates on data management activities, risks, decisions, and timelines, and escalate issues as appropriate.

• Review CRO financial reports, change notifications, and associated data management expenses to support appropriate scope, budget, and timeline oversight.

• Build constructive working relationships and navigate challenging situations with professionalism, respect, and a solutions-oriented approach.

• Contribute to the continuous improvement of data management processes, standards, tools, and templates; share best practices and align day-to-day decisions with company goals, study priorities, patient safety, and program success.

The Ideal Candidate will have:

• Bachelor's degree in Life Sciences, Health Sciences, Computer Science, or a related discipline; an advanced degree is preferred.

• At least 7 + years of clinical data management experience within the pharmaceutical, biotechnology, or CRO industry.

• Required hands-on experience with Medidata Rave EDC, eCOA and RTSM.

• Demonstrated experience creating, running, reviewing, and interpreting Medidata Rave reports and listings.

• Demonstrated experience testing clinical database builds, UAT scripts, edit checks, eCRFs, and database changes, including defect documentation and retesting.

• Solid understanding of database design, edit checks, data review, query management, external data reconciliation, and database lock processes.

• Strong knowledge of ICH-GCP and applicable regulatory requirements.

• Experience reviewing CRO study finance reports, change notifications, and data management expenses.

• Excellent written, verbal, and interpersonal communication skills, with the ability to communicate clearly with both technical and non-technical stakeholders.

• Strong organizational and prioritization skills, with the ability to multitask, manage competing deadlines, and maintain attention to detail.

Preferred

• Experience with Spotfire or similar data visualization and analytics tools.

• Experience working in a small to mid-sized biotechnology company environment.

• Familiarity with CDISC standards, risk-based data review methodologies, and external vendor data integrations.

Key Competencies

• Demonstrated ownership, accountability, and follow-through for study deliverables.

• Ability to work effectively in a high-pressure, fast-paced environment while maintaining quality and sound judgment.

• Ability to manage ambiguity, adapt to changing priorities, and make timely, risk-based decisions.

• Excellent communication, active listening, and stakeholder management skills.

• Collaborative and respectful team member who can build trust across functions and maintain productive relationships during challenging situations.

• Proactive problem-solving and risk-management mindset.

• Ability to influence without direct authority and drive accountability across internal teams and external partners.

• Commitment to company goals, patient-focused execution, data quality, compliance, and operational excellence.

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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