Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule inhibitors to help people with cancer not only live longer, but live better. The Company aims to address existing and emerging unmet needs with a precision oncology approach that improves survival and enhances overall well-being. Its discovery process combines deep insights in clinically validated biological targets and differentiated chemistry with the goal of designing therapies for unmet needs. 

We are seeking a Manager, Clinical Data Management to perform and/or oversee all clinical data management activities for assigned projects to ensure accurate, high quality management of clinical trial data for outsourced trials in a fast-paced environment. This position will report to the Head of Clinical Data Management. Responsibilities include but are not limited to the following:

• Serve as primary data management representative on cross-function project teams and ensure effective communication exchange
• Manage and collaborate with CROs to ensure that study deliverables and timelines are met
• Perform Data Management tasks and oversee CRO performance as needed
• Lead eCRF design and lead activities with external vendors developing and validating systems/applications for clinical trial data collection (e.g. EDC) to ensure quality and timely deployment
• Conduct trainings for appropriate users of data collection systems (e.g. EDC)
• Generate and/or review/approve study documents (e.g. Data Management Plans, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, study protocols)
• Ensure the quality of clinical data to meets standards for regulatory submissions
• Generate and/or implement the Data Quality Review Plan (DQRP) defining and documenting the data quality review strategy for each clinical trial in collaboration with cross-functional team, enabling the quality review of patient data supporting regulatory filings, publications and other high-profile business activities
• Generates and/or distributes data management metrics, data listings and status reports
• Contribute to the ongoing development, review, and revisions of data managemen
• Standard Operating Procedures (SOPs) and standard DM templates
• May supervise direct reports when needed

• B.S. /B.A. in a science or technical discipline degree with 6 years Clinical data management experiences, or M.S. degree with 4 years Clinical data management experience
• 3 years of experiences as study lead data manager
• Proficient in clinical data collection, cleaning and analysis for Phase I- IV clinical trials in a pharmaceutical industry/CRO
• Working knowledge of ICH/Good Clinical Practices (GCP), Good Clinical Data
• Management Practices (GCDMP), and related regulatory requirements. CCDM is preferred but not required
• Working knowledge of CDISC CDASH/SDTM standards, medical terminology, any medical coding dictionaries
• Working knowledge of different EDC platforms and other data collection systems (e.g. IRT, ePRO, etc.)
• Experience working in both the in-house and outsourced data management model
• Ability to manage multiple initiatives and shifting priorities within a small company environment
• Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment

The expected salary range for this position is $140,000 - $170,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This is a full-time remote position (40 hours/week). Occasional evening, weekend, holiday, and on-call work may be required as job duties demand. Occasional travel may be required. 

The statements contained herein are intended to describe the general nature and level of work to be performed. The statements are not to be construed as a complete and/or definitive list of the responsibilities, duties, and skills required of the employee. Furthermore, they do not imply a contract for employment and are subject to change with or without notice at the discretion of the employer.

 Enliven Therapeutics is proud to be an equal opportunity employer. All employment offers are contingent upon the applicant successfully completing a background screen.