Clinical Development Manager | Bio-Pharmaceutical
Remote – UK based
Up to £65k + up to 20% annual bonus
- Accountable for the overall operation of clinical studies including project planning, budget, resource management and contract research organization contact within the overall context of an approved clinical operational plan for the portfolio of products that are consistent with lifecycle program/company goals.
- Oversee all aspects for sponsored and investigator-initiated studies (IISs) according to the applicable Standard Operating Procedures (SOPs) and ensure all managed processes are compliant with internal SOPs and external regulations.
- Safeguard that assigned clinical research projects comply with the clinical protocol, the most recent requirements for Good Clinical Practice (GCP) and other applicable regulations.
- Oversee outsourced tasks and services and manage contractor relationships.
- Manage clinical supply activities for both companies sponsored led studies and IISs, including but not limited to, calculating supply strategy and volumes, label generation and approval, packaging and labelling and organising resupplies.
- Work with clinical supply vendors to ensure timely manufacture, packaging, release, and shipment of clinical trial material.
- Work with legal and sites to negotiate contracts for IIS’s.
- Maintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research.
WHAT YOU WILL NEED…
- University degree in a health-related field with a minimum of three (3) years direct clinical trial experience in a CRO or research-related organization.
- EU and US experience would be beneficial.
- Ability to work confidently work independently and as part of a team.
- Knowledge of clinical research process from Phase I through regulatory submission.
- Ability to manage multiple priorities within various clinical trials.
- Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings.
- Working knowledge of current ICH GCP guidelines.
- Great Pension Scheme
- Private Medical Insurance
- Discretionary Bonus Plan
- Paid Maternity and Paternity Leave