Crescent Biopharma20d ago

Senior Manager/Associate Director, Clinical Data Management

United States·WalthamFull-timesenior

OtherHealthcareData Management

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Overview

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,

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OtherHealthcareData 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. Please note, this person must be local to the Waltham, MA office.

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

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

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

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