Clinical Scientist (Oncology) Jobs

Clinical Scientist (Oncology, Cell/Gene Therapy)

12 Month Contract, extension possible

Fully Remote OR Local to Cambridge MA is a plus

MUST HAVE:

BS Degree Required, Advanced Degree preferred

Experience supporting oncology trials is a must

Experience with biologics or cell and gene therapy preferred

Will support Phase I/II, fully outsourced studies in North America

The Clinical Scientist will be responsible for global clinical trial delivery including the planning, management and reporting of trials in accordance with company plans/objectives, GCP, local country requirements and company standard operating procedures. This includes writing and/or reviewing protocols, interacting with sites for feasibility assessment, site selection, start up, study conduct, data cleaning, data review, and study close-out, for one or more clinical trials.

Responsibilities

• Review clinical trial data - monitor data quality and ensure appropriate quality measures are in place
• Provide guidance on protocol and procedures in the development of eCRF design
• Ensure consistency of study execution across studies to facilitate data analysis and regulatory filing
• Study specific vendor interaction and coordination
• Proactive stakeholder management and communication of progress and issues
• Plan and/or conduct site evaluation and initiation; develop and maintain effective relationships with clinical sites globally
• Support study design, translate scientific imperative into operational delivery of trials. Review and/or writing of study concept, protocol, study plans, IP management plans, CSRs
• Plan timelines, conduct study feasibility, risk assessment/management and contingency planning. Ensure timelines are communicated to all personnel assigned to the study (including vendors)
• Lead the cross-functional Study Conduct Team – drive operational delivery and facilitate issue resolution
• Liaise with clinical drug supply/manufacturing to ensure co-ordination for trial subjects
• Maintain TMF and ensure inspection readiness
• Review monitoring visit reports; liaise with monitors to understand any trends on data management issues/ICF issues/study binder issues/site staff issue to develop solutions

Qualifications

• Experience with biologics or cell and gene therapy is a plus
• Prior experience with clinical protocol development and/or regulatory submissions and management
• Previous leadership in a matrix environment
• EDC including trial management, data review, issuing and resolving queries, CRF design/review/ approval
• Minimum of a BA/BS in Life Sciences Degree
• 3+ years of industry-sponsored clinical trial management experience required.
• Strong knowledge of clinical operations and the regulatory process - experience independently running/managing multiple clinical trials preferably within the oncology area

Desirable

• Additional post-graduate scientific experience or qualifications, such as an M.Sc. or PhD