The Senior Clinical Operations Study Manager is responsible for the implementation and management of Clinical Research Studies to quality standards, within proposed timelines, and on budget, in accordance with clinical protocol and regulatory requirements. The Manager will apply knowledge of Clinical Operations, the scientific objectives of the clinical trials and best practices, to manage specific components of clinical studies against time, budget, and quality parameters. In addition, the individual will collaborate with other functions represented on internal and external project teams to ensure deliverables are being met. The individual will provide GCP expertise and engender best practices in related areas of oversight, including, for example, vendor management, study team leadership, and TMF structure and maintenance.
- Study team leadership/management: Act as the primary point of contact for the study and manage day-to-day communication and activities of the study team. This includes internal and external team members, vendors, and corporate partners. As needed, solve or lead the study team in developing solutions for day-to-day study issues. Drive all study team members to effectively communicate and coordinate activities. Create the agenda for and drives study team meetings to ensure they run efficiently and effectively. Oversee study-specific training to Clinical Operations and investigation personnel.
- Study execution and management: Oversee the coordination and management of activities of study execution including protocol feasibility, site selection, regulatory document collection, site initiation, site monitoring, data management, coordination of external parties such as steering committees, and site close-out in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies. Ensure the approval of GCP essential documents required for release of investigational product to investigational sites. Ensure ongoing review of blinded study data and deviations from clinical protocol. Develop corrective and/or preventative action plans to address any deficiencies in conduct of clinical study.
- CRO/Vendor Management: Collaborate with internal project team members to develop outsourcing strategy to facilitate the selection of high-quality service providers aligned with the strategy. Lead the vendor selection process (such as CROs) and negotiation of agreement terms, ensuring deliverables, costs, acceptance criteria and payment terms are clearly defined. Lead or assist in the development of the scope of work for all outsourced work, including budgets. Ensure effective tracking of study progress, data quality and vendor performance, based on pre-specified metrics. Participation in initiatives and/or other activities as requested.
- Study planning: Lead development of study documents, plans and processes, such as protocol, informed consent, and case report forms. Oversee development, implementation, and maintenance of study plans, including, but not limited to, data management plan and clinical monitoring plan. In collaboration with internal stakeholders, ensure detailed study schedule and timelines are created that are in line with estimates.
- Bachelor's Degree in science
REQUIRED SKILLS AND EXPERIENCE:
- A minimum of five years of experience in clinical trial management, including management of vendors.
- Proven track record of effectively working on late phase (i.e., phase 2 and 3) clinical studies
- Experience in resource and budget/financial management and people and time management
- Knowledge of clinical study guidelines (FDA, ICH, and GCP)
- In-depth understanding of the clinical trials process
- Excellent oral and written communication skills
- Must be willing to travel up to 10% of time
PREFERRED EDUCATION, SKILLS AND EXPERIENCE:
- Master's Degree
- Experience in CNS clinical trial management