Clinical Data Manager
Supports the Allakos Clinical Development and Medical Affairs/Bioanalytics teams by managing Data Management activities and personnel in the design and implementation of clinical studies. The position requires a highly-motivated individual to work collaboratively in a cross-functional team environment. This individual will play a key role in ensuring accurate, high quality clinical trial data in a fast-paced, start-up biotech environment. Overall responsibilities will include oversight of clinical data management activities from study start-up through study closure in support of trial objectives, regulatory submissions, publication activities and corporate goals. This position reports to the Vice President, Clinical Operations.
- Serves as the primary overseer/“point person” for Allakos clinical data management activities.
- Works with clinical, biostatistics and regulatory teams to develop Study Protocols and Statistical Analysis Plans. .
- Oversees the collaboration and coordination of the design and implementation of clinical protocols and data collection systems including the development and maintenance of electronic Case Report Form (eCRF), CRF Completion guidelines, edit check specifications, data transfer specifications, and database audit plans.
- Collaborates in the development, implementation and integration of IxRS systems, as applicable.
- Performs and organizes cross-functional User Acceptance Testing (UAT) of the integrated clinical databases
- Assists in the development of data quality plans.
- Proactively organizes on-going data review throughout the conduct of clinical studies to ensure timely and appropriate identification of errors, trends, and discrepancies.
- Responsible for the correction of errors and discrepancies through the site query process, for documenting permanent data issues, routinely communicating issues with team members and the delivery of a quality locked database for analysis.
- Ensures data management timelines for assigned projects are met, up to and including the timely delivery of Tables, Listings and Figures for individual studies.
- Oversees production of quality data deliverables for assigned protocols to support regulatory submissions and due diligence activities. Assists the Director of Medical Affairs and Bioanalytics in providing deliverables to support medical affairs and publication needs.
- Participates in the review of clinical and regulatory documents, as needed, to assure data integrity and quality.
- Assists with the development of standards and process documentation, including Standard Operating Procedures and Work Instructions.
- Supports compliance with industry quality standards, guidelines and procedures. Participates in the development of department SOPs and standards/templates with focus on CDISC implementation.
- Assists with the selection, development and evaluation of personnel and vendors to ensure the efficient operation of the function.
- Oversees projects that have been engaged with Contract Research Organizations (CROs), as well leads and manages internal projects.
- Participates in providing suitable input into corporate and department budget process and management.
- Other data management related duties as assigned.
Bachelor’s degree preferably in Life Sciences or Mathematics; an equivalent combination of education and applicable job experience may be considered. A minimum of 5 years progressively responsible experience in clinical data management in the pharmaceutical/biotechnology/CRO setting with 2 years’ experience in a leadership role.
- Previous experience managing projects in a Data Management/Bioanalytics group, with exposure to the complete DM study cycle (Start-Up, Conduct, Close-Out)
- Experience and understanding of ICH and GCP
- Experience with Electronic Data Capture (EDC) and IxRS systems
- Knowledge of medical terminology
- Knowledge of coding dictionaries (Medical Dictionary for Regulatory Activities -MedDRA, WHO Drug)
- Excellent verbal and written communication skills as well as interpersonal and organizational skills
- Proficiency in MS Office applications
- Proficiency with data management systems and knowledge and understanding of supporting technologies (e.g., EDC, IxRS, ePRO, SAS) and industry standards (e.g., CDISC)
- Self-sufficient and able to work with minimal oversight.
- Demonstrated skill at effectively communicating department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines. Able to earn and foster cooperation with and of others.
- Proven skill at effectively leading a cooperative team effort and organizing resources to achieve team goals. Able to make and prioritize process and resource decisions based on overall team needs.
- Willingness and ability to travel as required.
The salary is competitive and commensurate with experience and qualifications.
Interested applicants please send resume to email@example.com
Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.