Senior Clinical Data Manager

Covid- 19 Mandatory Vaccination Requirement

Throughout the pandemic, we’ve done all that we can to keep our employees safe, and the employees coming in have been careful to take precautions to reduce the risk of bringing Covid into our work environment. As we reopen our office, we’re mindful that the pandemic is not yet over, and young children are not yet vaccinated. We are committed to continuing to protect our team and keep our office safe.  Vaccination has proven to be the best thing you can do to protect yourself, your family, your colleagues and your community. Since we are striving for a 100% vaccinated workplace (including employees, contractors, vendors and guests), all NEW HIRES will be required to be fully vaccinated, and to present proof of their Covid-19 vaccination to our HR team as part of our on-boarding process.

SUMMARY:

The Senior Clinical Data Manager is responsible for providing technical oversight and management of clinical data management (CDM) activities in an outsourced model.  This role will perform review and approval of relevant CDM documents, validation of data systems, and general clinical data review and management.  The Senior Clinical Data Manager is responsible for delivering high quality and timely clinical data and documentation. 

RESPONSIBILITIES:

• Review and approval of CDM documentation, including but not limited to electronic Case Report Forms (eCRFs), Data Management Plans, Data Validation Specifications, Data Transfer Agreements, Data Review Guidelines, Data Analysis Plans and eCRF Completion Guidelines
• Ensure delegated and outsourced tasks are performed on time with high quality standards
• Lead the CDM process from study start-up through database lock for Phase I and Phase II studies
• Able to work successfully with minimal supervision and Collaborate in a cross-functional matrix-style organization
• Lead and actively participate in User Acceptance Testing (UAT) for clinical study databases
• Review clinical study documentation including protocol, project timelines, meeting minutes, and study notes to file and contribute from the CDM perspective
• Review CDM files for completeness and accuracy and ensure archival according to SOPs
• Perform CDM cleaning activities including processing queries, performing ongoing data review, identifying issues, data trends and tracking them through resolution
• Perform oversight for the data transfer process

EDUCATION AND EXPERIENCE: 

• Bachelor’s degree with at least 5 years of pharmaceutical, biotech or CRO experience; small biotech/pharmaceutical company experience is a plus
• Oncology experience preferred

• Experience with vendor oversight using data management methodologies and technologies
• Working knowledge of FDA, GCP, ICH, SDTM standards and CDISC data handling standards and specifications as well as clinical trial methodology
• Medidata RAVE experience required
• Demonstrated skills with Microsoft Office (Excel, PowerPoint) required
• Experience working with safety data and coding dictionaries (MedDRA and WHODD)
• Experience with J-Review, Spotfire or similar data review/visualization systems are a plus

REQUIREMENTS:

• Strong vendor management skills
• Project level CDM experience
• Thorough knowledge of the CDM process and experience in specialized data management skills (e.g., SAE reconciliation, central laboratory, data reconciliation)
• Proficiency with clinical data collection and review process; proven success in achieving data milestones from CRF design to database lock
• Demonstrated advanced knowledge of data management systems, practices, and standards

• General knowledge of cross-functional clinical development is necessary
• Flexible personality, creative problem solver with proven ability to work independently and collaboratively in a fast-paced, results-oriented, and dynamic environment
• Strong interpersonal and leadership skills, positive outlook and ability to work well within a matrix team structure
• Flexible work model with role based in Cambridge, Mass