Senior Manager/Associate Director, Clinical Data Management

Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies either as single agents or as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.

We are seeking a Clinical Data Management Lead who will oversee the clinical database build, data cleaning, and delivery timelines in partnership with outsourced CROs. You will be responsible for developing and maintaining key data management documents (e.g., the DMP, CCGs, DTAs) and will report to the Head of Data Management.

Responsibilities

• Manage all clinical data management aspects from start-up and database design through close-out and archival of studies
• Act as lead Clinical Data Manager on one or multiple clinical trials
• Oversee all activities outsourced to clinical research organizations, including review and approval of key deliverables (e.g., Data Management Plan, edit check specifications, CRF Completion Guidelines)
• Act as primary point of contact for both internal and external cross-functional teams
• Provide subject matter expertise to eCRF design, build, testing, and validation
• Lead data cleaning activities with support from the cross-functional team
• Responsible for delivery of quality data to support study decisions, abstracts, posters, and presentations
• Oversee eCRF metrics to monitor protocol data collection compliance
  
  

Education & Experience

• Bachelor’s degree in a scientific or health-related field preferred
• 6 years of clinical data management experience within biotech/pharma/CRO environments; leading Phase I-III global clinical trials, preferably in a clinical-stage biotechnology company managing outsourced clinical trials
• Experience in oncology preferred
• Experience with Medidata EDC preferred
• Strong understanding of FDA, ICH, and GCP guidelines
• Understanding of clinical database design utilizing SDTM standard terminology
• Familiarity with data visualization tools to support data review
• Ability to lead data management responsibilities within a fast-paced cross-functional team
• Experience in oversight of CRO data management responsibilities
• Proficiency in handling multiple data transfers internally and externally
• This role may require up to 5% travel
  
  

What We Offer

• Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment
• Competitive compensation, including base salary, performance bonus, and equity
• 100% employer-paid benefits package
• Flexible PTO; also, two, one-week company-wide shutdowns each year
• A commitment to your professional development, with access to resources, mentorship, and growth opportunities
  
  

Salary Range

The salary range for this position is $X to $X. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

Additional Description For Pay Transparency

The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation – Unlimited PTO; Sick time – 10 days per calendar year; Holiday pay, including two Company shut downs; Parental Leave – 16 weeks within one year of the birth/adoption/foster care of a child; FMLA; Military Leave. Additional information can be found - https://www.crescentbiopharma.com/careers/#benefits

Please Note

Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.

Please note, Crescent does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between Crescent and the agency. Crescent will not pay any fees related to unsolicited resumes.