Senior Manager, Clinical Operations - Neurology
Permanent
Competitive Salary
Hatfield

Exciting opportunity to work for our International pharmaceutical client, who is looking for an experienced Clinical Operations Lead. You will be responsible for the overall management of clinical studies in multiple Phases including, but not limited to, the development of study start-up materials, clinical supplies, case report forms, contracts and budgets, investigator meetings, and regulatory document filing.

If you have demonstrated learning agility to lead studies in several high profile global programs, then this could be the role for you, where you will work with other team members to coordinate the preparation of study protocols and final study reports. A detailed understanding of overall strategic direction; interrelationships and business needs is required.


Main duties and responsibilities:
* Sets objectives, delivers results and implements policies and operational targets that have a direct impact on the work unit or operational outcome
* Work may include policy changes or recommendations
* Individual contributor with specialised knowledge
* Executes work procedures in a project context. Consistently exercises judgement and discretion within generally defined procedures
* Technical expert with sufficient expertise and experience to be considered for sensitive or complex assignments
* 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 organisation 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
* 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
* Assesses risks and develops creative solutions
* Supports the timely development and / or review of all study related documents
* Serves as primary interface with CROs to ensure appropriate study/operational strategy is followed
* Participates in cross-functional process improvement projects
* Manages team finances in compliance with financial standards and guidelines


Skills & Experience required:

* Bachelor's degree in biological science, nursing, pharmacy or equivalent as a minimum
* Demonstrated experience in the pharmaceutical industry leading large, global studies with multiple vendors involving management of submission timelines and associated processes
* Prior experience as a field monitor/ CRA
* Demonstrated experience in the identification of emerging risks and the ability to collaboratively champion solutions within a multi-disciplinary drug development team to help resolve challenges is required
* Solid project and vendor management, analytical and problem solving skills
* Prior experience with development and tracking of study budgets in excess of $20M
* Excellent written and verbal communication skills
* CNS experience preferred Epilepsy or AD/Dementia

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.

Gi Group Holdings Recruitment Limited group of companies includes Gi Recruitment Limited, Draefern Limited, Gi Group Recruitment Ltd, INTOO (UK) Limited, Marks Sattin (UK) Limited, TACK TMI UK Limited and Grafton Professional Staffing Limited. We are committed to protecting the privacy of all of our candidates and clients. Following some recent changes to data protection laws we have updated our Privacy Policy. To view a copy and to help you understand how we collect, use and process your personal data please visit the Privacy page on our Gi Group UK website.