Senior Manager, Clinical Operations - Oncology
Exciting opportunity to work for our International pharmaceutical client, who is looking for an experienced Clinical Operations Manager. You will be responsible for the leading the cross-functional study team in managing one or more clinical studies in Oncology, 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. Ensuring that the studies are executed according to ICH/GCP guidelines, applicable regulatory requirements and Company standard operating procedures. Manages performance and development of assigned direct report(s).
Main duties and responsibilities:
* Has primary accountability for operational study level time, cost and quality deliverables
* Manages overall study budget - for large, global or multiple regional studies
* 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 judegment 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.
* 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
* Comprehensively assesses options to address study issues
* Serves as primary interface with CROs to ensure appropriate study/operational strategy is followed
* Selects / approves monitoring CROs and study sites
* Assists the review of 3rd party (contractors, consultants and vendors) work product and deliverables to recommend approval of payment of invoices or escalate issues when appropriate
Skills & Experience required:
* Technical expert with sufficient expertise and experience to be considered for sensitive or complex assignments
* Experience in clinical operations methods and processes in industry setting required
* BS/MS in relevant field
* Demonstrated experience in the pharmaceutical industry leading large, global studies with multiple vendors involving management of submission timelines and associated processes
* Solid project and vendor management, analytical and problem solving skills
* Prior experience with development and tracking of study budgets
* Excellent written and verbal communication skills
If you are interested in this role and feel that you have the right skills then please click apply.
For further details, please contact us on 01707 247259
Gi Group Pharmaceuticals provides a tailored Account Managed Service and dedicated Pharmaceutical recruitment team and partners with many different Pharmaceutical and Biotechnology clients throughout the globe and the United Kingdom.