Clinical Operations Lead
Proclinical is currently recruiting for a Clinical Operations Lead with a biotechnology company located in Cambridge, MA.
- Develop scientifically robust, operationally feasible and clear protocol concepts and protocols, and feasible protocols and robust data monitoring plans
- Leverage appropriate on-going data review to identify and mitigate patient, study design, data or study conduct issues
- Ensure all operational aspects support end point integrity and data validity.
- Has a robust understanding of the study design including rationale, end points and patient population, and will ensure that the operational strategy supports both feasibility and scientific integrity.
- Develop and leverage Phase expertise (e.g. Phase I, II, III, IV), therapeutic knowledge, as well as internal and external data to develop protocols and expert's operational strategy for one or more clinical studies.
- Develop operational strategy (including ancillary vendors) aligned with the program strategy and incorporating country input through the study Clinical Country Lead
- Oversee the tactical execution of the operational strategy by the partner CRO; effectively leads the study through oversight of the CRO
- Drive performance, quality, timelines and relationships through the CRO partnership model
- Chair the [Study Management Team] in partnership with the CRO study Lead of the [Study Management Team]; ensures the CRO creates appropriate risk mitigation plans and is effective in proactively identifying and resolving issues.
- Partner with GCO Vendor Management to escalate issues, sharing best practices and leveraging the Vendor Operations Relationship Manager for issue resolution.
- Champion best practice development in Phase planning and seeks opportunities for innovation and efficiency with the Clinical Operation Management group
- Seek interdependencies and synergies with other trials and programs to enhance superb planning and execution across all studies in a phase
- Follow established procedures and SOPs; seeks ways to improve and streamline processes to support the GCO CRO outsourcing model
- Embodies a culture of continual improvement by seeking consistency and efficiency in processes and fully supporting the new CRO partnership model
Skills and Requirements:
- Deep understanding of clinical development within one or more Phases of trials (Phase I, II, III, IV) and a working understanding of cross functional drug development.
- Scientific learning agility to quickly develop a sound working knowledge of new therapeutic areas.
- Ability to establish operational plans and support the CRO in the execution of the plans. Requires a balance of scientific and operational/project management and team leadership expertise.
- Must be able to build effective relationships across and up and down the organization.
- Excellent project management skills, including risk assessment and contingency planning.
- Must have effective prior CRO management skills and be able to adapt to the GCO outsourcing model.
- Able to partner with other functions and both internal and external stakeholders.
- Excellent leadership, communication, management and organizational skills, along with problem solving, conflict resolution, and team building skills.
If you are having difficulty in applying or if you have any questions, please contact Zachary Hines at 215-531-6914.
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.