Senior Manager, Data Management

The Company:
With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer.  Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. 

The Role:

Reporting to the Sr. Director, Data Management, the Senior Manager, Data Management role is responsible for the oversight of all aspects of the clinical trial data management process from study start up through study closeout. The role will be responsible for oversight of Data Management vendors to ensure timelines and deliverables are met.

Demonstrate ability to manage multiple critical timelines, build effective relationships with vendors and external partners and to work cross-functionally in a productive manner to support the development of our clinical programs all while demonstrating our core values are important aspects of this role.

Responsibilities:

• Lead studies and function as the Data Management primary point of contact for all study team members and vendor partners.
• Participate in process improvement initiatives, as needed.
• Serve as an active member of Clinical Study Teams.
• Work with other functions to manage timelines and ensure that clinical data management deadlines are met.
• Provide oversight of data management CRO and other third-party vendors as required.

• Oversee external data from third-party vendors such as central laboratories in support of timelines and data-related deliverables.
• Perform User Acceptance Testing (UAT) activities for clinical trial database build and modifications.

• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics, audit reports, and input from project team members and other stakeholders.
• Train other personnel on study-related items and data management principles, as needed.
• Review and provide feedback on draft protocols, Statistical Analysis Plans, CSRs, and other documents as required.
• Contributes to the development of Data Management processes and standards.

Competencies Include:

• Strong interpersonal and communication skills, with expertise in successfully managing external stakeholder relationships.
• Demonstrated project management and prioritization capabilities.
• Ability to think critically with strong attention to detail.

 Qualifications:

• Bachelor’s degree or higher in a scientific or healthcare discipline preferred.
• 7+ years of experience in Data Management in the CRO/pharmaceutical/biotechnology industry.
• Working knowledge of EDC systems – preferably Medidata RAVE.
• Proficiency in all areas of Data Management activities required.
• Knowledge of clinical data management outsourcing with full-service CROs.
• Strong oncology experience required.
• Understanding of ICH and regulatory environment as it pertains to data management.
• A working knowledge of SDTM and CDASH principles and other industry guidelines strongly preferred.

Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.

Nuvalent is aware that many companies are dealing with fraudulent job postings on third-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities.

Please be advised that all legitimate correspondence from a Nuvalent employee will come from “@nuvalent.com” email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a “[email protected]” email address. There are no variations of these email addresses and Nuvalent would not request personal and/or financial information via email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews via phone, video conferencing and/or in-person.

If you believe you have been contacted by anyone misrepresenting themselves as an employee of Nuvalent, please contact Nuvalent at 857-357-7000. Thank you.