Manager/Senior Manager, Data Management

Waltham, Massachusetts
Development – Development Operations /
Full-Time /
Hybrid
Who We Are
Cogent Biosciences is a publicly traded biotechnology company developing real solutions to treat genetically driven diseases. With a focus on rational drug discovery and development, we are leveraging validated biology to advance precision therapies designed to address the true underlying drivers of disease and provide real hope for patients. Cogent’s lead therapeutic candidate, bezuclastinib (CGT9486), is a precision kinase inhibitor designed to selectively and potently inhibit the KIT D816V mutation. This mutation is responsible for driving a rare and serious condition called Systemic Mastocytosis (SM), which can severely impact many different tissues and organs in the body. We are also studying CGT9486 to treat advanced gastrointestinal stromal tumors (GIST), which have a strong dependence on oncogenic KIT signaling. We are currently enrolling two Phase 2 clinical trials for patients with SM and a global Phase 3 trial for GIST patients.

Our Team
https://cogent.culturehq.com


Job Summary: 

As Manager or Senior Manager of Clinical Data Management, you will be responsible for Clinical Data Management activities across multiple projects/programs, managing the end-to-end clinical data flow and ensuring timely project execution with quality data deliverables.  In this role, the ideal candidate must be comfortable working independently as well as managing interactions with and between team members, both internally and externally. 

What You Will Do:

    • Lead/perform internal data reviews. 
    • Oversight of third-party reconciliation. 
    • Manage database change controls including performing User Acceptance Testing 
    • Develop or lead the review of all DM documents, including Data Management Plans (DMP), eCRF Completion Guidelines (CCGs), Data Transfer Agreements, etc.   
    • Single point of contact for the execution of data management deliverables on assigned trials/programs.  
    • Attend, if required, any protocol review meetings and act as subject matter expert for proper data capture based on protocol requirements 
    • Accountable for development of task related timelines, project management of all end-to-end data management deliverables in collaboration with cross functional team members and vendors on assigned studies. 
    • Lead Case Report Form Design according to the protocol with all Study Team members  
    • Oversight of CROsin ensuring that out-sourced data management tasks are performed according to GCP, approved SOPs, and protocol.   
    • Participate in regular team meetings and provide input when appropriate. 
    • Support study-level/drug program audit and inspection readiness activities as needed. 
    • Ensures that out-sourced data management tasks are performed according to GCP, approved SOPs, and protocol.   

What You Bring:

    • 5+ years as a Trial Data Manager with full accountability across study start-up, conduct, and lock.
    • Robust experience with core data management activities, EDC (eg, Medidata Rave) and use of Data Review tools
    • Deep understanding of drug development and biopharmaceutical industry required.
    • Ability to manage multiple, competing priorities.
    • Experience overseeing outsourced clinical trials.
    • Self-motivated with the ability to drive exceptional results/outcomes with aggressive timelines.
    • Primary contact for clients with little oversight required
$106,000 - $150,000 a year

Our Locations

Waltham, MA: Our Boston office includes an open office layout that has recently undergone a makeover designed for collaboration and giving our employees the best work place possible. Free access is provided for both on-site parking and gym facilities in the building.

Boulder, CO: We have just moved into our new state-of-the art Research Facility in the fast-growing biopharmaceutical hub in the greater Denver/Boulder corridor.  Our CEO is based full-time in this location and we are proud to call this the home of Cogent’s discovery research organization.

Our Offer To You

To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), competitive time-off, a 401(k) plan, and commuter/parking benefits.

We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law. All employment is decided on the basis of qualifications, merit, and business need.