Ref #: 24717

Employment type: Permanent - Full-Time

Location: United Kingdom (home-based)

Posted: 18-Oct-2020

Description

Are you an experienced Clinical Study Manager/Leader looking for a new challenge?


Here at DOCS Global (FSP department of ICON Clinical Research) we are partnered with a multinational pharmaceutical company who have requested experienced Clinical Study Managers/Leaders to coordinate their medical evidence generating Phase IIIb/Phase IV global clinical trials for their exciting portfolio of oncology assets.

Successful applicants to the Evidence Delivery Manager (EDM) roles will be expected to be experienced in the project management of international clinical or medical evidence generating trials through set-up, management and reporting. A track record of leading international clinical trials, project managing/leading oncology trials, prior experience delivering studies utilising external service providers (ESPs) and medical evidence experience are all desirable attributes.

As an EDM you will either lead a multi-disciplinary study team made up of sponsor subject matter experts and ESP representatives, or play a supportive role to the study leader depending on study complexity, study type, phase and individual experience. You will be accountable for ensuring the companies ESPs deliver their studies to the agreed time, cost and quality specifications. You will be involved in the following activities: Sponsor oversight, ESP management, stakeholder management, budget management, risk management, quality management, business reporting, maintenance of business systems, the facilitation of sponsor contributions to the study teams efforts and day to day problem solving/issue resolution/option evaluation to maintain delivery within agreed tolerances.

Alternatively, possibilities exist for applicants take on the operational oversight of a portfolio of externally sponsored studies of one/more of the companies oncology assets. This will involve working with country affiliates/marketing companies to prepare contracts with external investigators to conduct such studies, agreeing suitable time schedules for delivery, ensuring sponsors meet their contractual obligations in maintaining the companies business systems and that marketing company representatives fulfil their responsibilities in supporting the companies external sponsors. To that end experience in managing portfolios of externally sponsored research is also a desirable attribute.

Finally EDMs will be expected to support continuous improvement by developing expertise in a specific area of development, serving as a point of contact for best practice and contributing to the maintenance and development of guideline documents and training materials.

We're hoping to connect with senior candidates with the experience of the management of Global Clinical or Evidence Delivery trials, and at least 7 years' Pharmaceutical Industry experience.

Please contact dominic.brady@docsglobal.com for a more detailed discussion and detailed job description.
Thank you