Job Description

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.

Key Responsibilities

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

Qualifications & Experience

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

Valid through: 3/16/2021