Contractor, Senior Manager- Clinical Data Management

About Generate Biomedicines:

Generate:Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.

We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!

Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received over $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees.

The Role:

At Generate Biomedicines, our portfolio continues to evolve, and projects continue to move rapidly into clinical development creating greater complexity of collaboration, information sharing, and need for coordination. The Contractor, Senior Manager- Clinical Data Management will provide expert-level support in the planning, execution, and oversight of clinical data management (CDM) activities across one or more clinical trials. This role will act as a lead for assigned clinical trials, ensuring the quality, integrity, and timeliness of clinical data deliverables. The consultant will collaborate with internal stakeholders and external vendors to manage end-to-end CDM tasks in accordance with regulatory guidelines and company standards.

**This is a remote, full-time Contractor position for six months.**

Here's how you will contribute:

• Act as the lead data manager for assigned clinical trials from start-up through database lock.
• Review, and implement data management documentation such as:
• • Data Management Plan (DMP)
  • CRF design and CRF Completion Guidelines
  • Edit check specifications
  • Data review and discrepancy management guidelines
• Lead database build and UAT for EDC platforms (e.g., Medidata Rave).
• Drive data cleaning activities to ensure database quality and readiness for interim/final analyses including regular review of metrics, data issues and update slides for team meetings.
• Monitor data reconciliation activities with external vendors (e.g., labs, ECG) and Serious Adverse Events (SAE).
• Oversee CRO/vendor performance and ensure adherence to timelines and data quality expectations.
• Collaborate with cross-functional teams i.e. clinical operations, biostatistics, safety, and programming teams to ensure alignment on data flow and delivery milestones.
• Create and manage data deliverable timelines and tasks. Collaborate with CROs to manage timelines and deliverables for data management activities.
• Maintain and QC study-specific trackers and metrics dashboards.
• Support or lead database freeze/lock processes, including freeze/lock for final, statistical or interim reviews.
• Assist in departmental development, review, and revision of Data Management Standard Operating Procedures (SOPs), plans and guidelines.
• Recommend process improvements, tools, or automation opportunities to enhance data management efficiency.

The ideal candidate will have:

• B.S with 7 + years or M.S. 5 + years of experience in Clinical Data Management at CRO/pharma/biotech.
• 5+ years of progressive experience/expertise with Medidata Rave EDC and eTMF.
• Prior consulting or contract experience preferred.
• Knowledge of regulatory standards (ICH-GCP, FDA, EMA) and data standards (CDISC).
• Strong understanding of clinical trial lifecycle and data flows.
• Exceptional communication, time management, and problem-solving skills.
• Ability to work independently with minimal supervision in a remote or cross-functional environment.
• Excellent interpersonal and communication skills.

Nice to have (optional):

• Experience supporting IND submissions.
• Familiarity with data management tools.
• Therapeutic area experience in [e.g., oncology, infectious disease, immunology].
• Experience supporting global trials and working with international teams.
• Familiarity with Risk-Based Monitoring (RBM), centralized monitoring, and ePRO/eCOA platforms.

Why Join Us:
At Generate:Biomedicines, we are pioneering generative biology to create novel therapeutics that could transform patient lives. You will join a mission-driven team that values collaboration, innovation, and continuous growth. As part of our Clinical Development organization, you will help build scalable, digital-forward data practices in a company poised to redefine what's possible in biomedicine.

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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