SR. MANAGER, CLINICAL OPERATIONS (CLIN-002)

The Sr. Manager of Clinical Operations is responsible for the management of all aspects of the trial activities from start-up to delivery of the final study report. This individual is responsible for the quality of all work done on the trial by establishing quality control procedures and must ensure adherence to all SOPs. 

The Sr. Manager of Clinical Operations serves as the leader and coordinator to execute Phase 1 oncology clinical trials while providing the groundwork for the upcoming Phase 2 trials. Responsibilities include creating an integrated clinical development plan aligned with the investigational product strategy to include scope, budget, timeline, and risk assessment. This position leads the clinical team’s identification and selection of CROs, KOLs, and investigation sites and manages the CRO and all CRAs. 

The Sr. Manager of Clinical Operations leads and has expertise in implementing, applying, and integrating clinical project processes and promoting open and efficient communication among and between various members and stakeholders. They will also oversee and administers the budgets and schedules the external audits. They will be accountable for achieving successful delivery of GenVivo clinical activities at the project level by meeting company and regulatory requirements according to time, quality/scope, and budget constraints. 

Education and Experience: 

• A Bachelor’s or Master’s degree (preferred) in Life Sciences, or a healthcare-related field. 

• Four or more years of clinical operations experience for CPM; with increasing levels of responsibility, in the Pharmaceutical, Biotechnology, Medical Device or CRO industry is required. • Five or more years of clinical project management experience at a sponsor or CRO company is preferred. 

• Experience in early phase trials (Phase I-II); Phase III experience desirable.

Essential Functions and Responsibilities: The below statements are intended to describe the general nature and scope of work performed under this position. This is not a complete listing of all responsibilities or skills required. Other duties may be assigned. 

• Serves as the leader and coordinator for the execution and management of Phase I and Phase II clinical trials in oncology. 

• Leads the team’s identification and selection of CROs, KOLs, and investigational sites. 

• Manages the CROs in the initiation, management, and completion of clinical studies per ICH guidelines, GCP, and company SOPs. 

• Provides clinical input and manages the study team’s development of the key study documents, including protocols, ICFs, IBs, SRMs. 

• Leads the completion of clinical sections for the regulatory filings, including INDs, amendments, and annual reports. Etc. 

• Manages and reports study timelines, status updates, and alerts project team of potential delays. 

• Provides clinical input into cross-functional activities, including assisting with project flow and input on strategic decisions in manufacturing. 

• Manages the overall quality of the study data. 

• Leads problem-solving and resolution efforts to include management of risk, contingencies, and issues. 

• Provides specific training and education for internal and external project team members as needed. 

• Meets objectives of the annual budgetary plan. 

• Ensures project deadlines and performance standards are met. • Operates both independently and as a team member depending on current company priorities.

 • Exhibits a professional manner in dealing with others, working to maintain constructive working relationships. 

• Supports the mission and strategic plan of the Company. 

• Requires international traveling.

• Performs other duties as assigned. 

Required Knowledge, Skills, and Abilities:

• Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and data management methods. 

• Global trial and Therapeutic experience in oncology. 

• Must possess a strong understanding of the clinical drug development, GCP, and the regulatory requirements for clinical trials. 

• Must have experience in managing and working with CROs. 

• Effective leadership skills, strong communication competency, and proven ability to foster team productivity and cohesiveness. 

• Able to anticipate change and show flexibility. 

• Proficient in computer skills, including Microsoft Office (Word, Excel, PowerPoint) and others as applicable. Excellent understanding of MS Project.

 • Ability to work highly independently, organize work with attention to detail ‎and accuracy; demonstrated skill in assessing timelines and coordinating numerous ‎assignments and projects simultaneously under heavy and fluctuating workloads and ‎conflicting deadlines. 

• Excellent organization skills with attention to detail and accurate record keeping. 

• General knowledge of Federal and State regulatory requirements in a GxP environment. 

• High degree of discretion in dealing with confidential information. 

• Ability and willingness to work flexible hours when needed. 

• Demonstrated ability to work independently and in a team environment. 

• Excellent written, verbal, and interpersonal communication skills. 

• Elligible to work in the U.S.
 

Job Type: Full-time