Proclinical is seeking an Associate Director, Clinical Operations for a cutting-edge biotech company located in Cambridge, MA.
The Associate Director, Clinical Operations oversees the details of complex clinical projects and contributes to defining the overall program strategy. In this role, you will provide program strategic direction and oversight of clinical research activities, including study design, protocol development, study placement, data collection systems, and final reports throughout all phases of clinical development. This position is an effective team leader who is able to guide/direct less senior staff to achieve desired results.
Must be eligible to work in the US.
Job Responsibilities:
- Meets departmental and project productivity and quality metrics and provides financial and management accountability to a wide range of audiences
- Partners directly with or guides staff to partner with preclinical, regulatory affairs, medical monitor, biometrics, and medical writing to develop protocol and study designs and other key study and program deliverables
- Participates in Protocol, IB, ICF, Regulatory submission documents, CRF, CSR development and review and provides direction to junior staff to manage the process, as necessary
- Effectively discusses and represents study data across the company; collaborates with medical writers and investigators to write, publish and present data
- Develops tracking tools and oversees project budgets, study timelines, and deliverables
- Participates in development of Clinical Operations Plans, Clinical Research Organization (CRO) outsourcing strategy, and key performance indicators (KPIs) with CRO and reviews KPIs during projects.
- Proficient in developing and tracking metrics and assessing clinical operations performance for multiple projects
- Identifies and reports potential program issues and resource deficiencies effectively and in a timely manner and implements corrective action
- Organizes logistics and partners with supply operations to manage clinical trial product supply and labeling of study drug as required by the clinical program
- Assists in the development of global department standards and successful implementation of process improvements and change
- Manages performance, development and growth of junior staff to support and guide them to improved efficiency and effectiveness at prioritization and problem solving; highly experienced as a line manager
- Active participation as a member of the Leadership Team; may be required to represent Clinical Operations on cross-functional partner teams
If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at +(1) 617-830-1769 or b.forsen@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
#LI-BF1
INDCR
.png)
