Global Life Science Hub is excited to collaborate with an innovative biopharmaceutical company leading the way in revolutionizing the life science industry. They are dedicated to developing groundbreaking medicines that address the most pressing unmet medical needs. Their pioneering breakthroughs in oncology offer new hope to cancer patients, while their remarkable advancements in CNS disorders and infectious diseases provide relief to individuals facing challenging health conditions.
With a proven track record, they have successfully discovered and commercialized over 15 drugs, establishing themselves as a true industry leader. Each day, they make significant progress in advancing both small molecule and biological drug candidates, pushing the boundaries of medical innovation.
Position: Senior Clinical Data Manager
The Senior Clinical Data Manager plays a vital role in collaborating with the Biostatistics, Programming, Clinical, and Medical Research teams. They are responsible for overseeing the CRO DM or managing all in-house data management activities, ensuring data integrity, and completing trials within specified timelines. This position involves close partnership with cross-functional groups and decision-making responsibilities regarding trial designs and timelines.
- Support or manage multiple studies in-house, providing CRO oversight as required (may act as the Trial Data Lead)
- Coordinate database build, design CRF (Case Report Form), author Data Management Plan, Data Validation Plan, Edit check specifications, and CRF Completion Guidelines for in-house studies
- Review and provide guidance to CRO on outsourced Data Management activities, including CRF design, Data Management Plan, Data Validation Plan, Edit check specifications, and CRF Completion Guidelines
- Participate in User Acceptance Testing activities as necessary
- Collaborate with the Safety team and oversee SAE (Serious Adverse Event) reconciliation
- Conduct review of clinical trial data, write and resolve queries, track data cleanliness, and perform tasks required for database lock
- Provide trial-related support to cross-functional groups such as Biostatistics, Clinical Research, etc.
- Assist in developing SOPs (Standard Operating Procedures) and Working Practices
- Attend meetings and report on study status, metrics, timelines, etc.
- Perform other data management department and trial-related activities as assigned
- Make decisions regarding trial database and CRF designs, timelines, vendor selection, and CRO oversight
- Bachelor’s degree in a science-related field
- 3-4 years of experience in clinical data management
- Strong project management skills
- Excellent verbal, written, and interpersonal communication skills
- Must reside within a commutable distance to our corporate offices in Florham Park, NJ
- Prior experience working with studies across all phases of Clinical Development (Phase I-III)
- Specialized experience with Phase I studies, Post Marketing Surveillance studies, or Real World Data is a plus
The Global Life Science Hub are a niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.
If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.glshub.com