Senior Manager, Clinical Operations
Charlene Dutchman is recruiting for Senior Manager, Clinical Operations to join a leading Pharmaceutical company based in Hertfordshire, to work on a full time, permanent basis.
As a Senior Manager, Clinical Operations you willspecifically focus on providing a resource as global clinical operations lead. You will typically lead the cross-functional study team in managing one or more outsourced clinical studies globally or within specified regions within the Neuroscience & General Medicine PCU, ensuring that study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data are acceptable and suitable for regulatory submission. The role will also involve management of clinical CRO and technical vendors and ensures that the studies are executed according to ICH/GCP guidelines, applicable regulatory requirements and company standard operating procedures.
Key Accountabilities/Responsibilities will include the following:
- Sets objectives, delivers results and implements policies and operational targets that have a direct impact on the work unit or operational outcome
- Executes work procedures in a project context. Consistently exercises judgment and discretion within generally defined procedures
- Presents concepts, facts, and reports to mid-level internal and external clients to advise of key trends and issues
- Contact with clients and external vendors and troubleshooting routine client inquiries. May represent the organization as a prime contact for technical matters of significant complexity
- Directs the activity of a work team project within the department. May have responsibility for management of highly skilled professional employees
- Work is completed under limited supervision
- Has primary accountability for operational study level time, cost and quality deliverables
- Manages overall study budget - for large, global or multiple regional studies.
- Coordinates all operational clinical research activities for regional / global studies
- Manages all aspects of study progress from start-up to close-out activities in accordance with ICH/ GCP guidelines
- Contributes to preparation of teams and documents for inspections
- Assesses risks and develops creative solutions
- Escalates issues to Unit leadership as appropriate
- Supports the timely development and / or review of all study related documents (e.g., PCS, Protocol, CRF etc.) and operational feasibility assessments
- Serves as primary interface with CROs to ensure appropriate study/operational strategy is followed.
- Evaluates vendor proposals against company terms and manages CRO's for successful conduct of clinical trials.
- Participates in cross functional process improvement projects.
As a Senior Manager, Clinical Operations, you will have the following qualifications, skills and experience:
- BS/MS in relevant field.
- Experience in clinical operations methods and processes in industry setting required.
- Proven track record of leading cross functional teams, people coordination, mentoring of junior colleagues.
- Experience in Neuroscience indications and especially Alzheimer's Disease preferable.
- Experience of CRO and technical vendor management essential to ensure delivery of complex multi-national outsourced studies to time and budget.
- Full understanding of current ICH/GCP guidelines.
For more information or to apply for this position, please contact Charlene Dutchman on 01246 45 77 33 or email email@example.com. Alternatively, please click on the link to apply online now.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL34895 in all correspondence.