Senior Clinical Project Manager - Home Based

Project Delivery - Project Delivery
Ref: 252 Date Posted: Tuesday 03 Sep 2019
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A well-established and reputable client of ours is actively looking for a Senior Clinical Project Manager to be responsible for the delivery and day-to-day management of complex projects within the clinical operations department. They are a circa £50m turnover, private equity backed group looking to grow their successful company and continue to be a market leader in their industry.

They are flexible with remote working (up to 4 days a week), however do require travel to the Hertfordshire based office at least once a week.

Key Responsibilities

- Manage all operational aspects for the implementation of clinical trials activities from study start-up through database lock

- Lead global and/or regional Clinical Study Management Team(s) in implementation of clinical trials, ensuring the studies are performed and conducted in compliance with ICH-GCP guidelines, SOPs and all applicable regulatory requirements for the allocated study

- Liaise with the Medical, Regulatory Affairs and Drug Safety, Medical Affairs and Clinical Operations staff to ensure timely, high quality and profitable delivery of projects.

- Provide input into and/or develop study related materials such as Trial Monitoring Plans, Communication Plans, Data Management Plans, eCRF forms and completion guidelines, protocols, patient informed consent drafts, site instructions for specimen collections, and study drug order forms as required.

- Perform and/or overseeing site monitoring visits for clinical trials as needed.

- Track patient recruitment and progress to study timelines; supporting safety reporting and ethics committee submissions; maintain and report metrics for clinical site performance.

- Provide oversight to staff maintaining clinical trial master files to ensure their compliance with required regulatory and GCP quality standards and consistency with SOPs.

- Work closely with Business Development personnel to identify new clients and assist with the preparation of business proposals.

Key Experience Required

- Science Graduate, or appropriate level of experience as a health care professional.

- A higher degree or Project Management qualification is desirable.

- At least 5 years' experience in study Project Management and prior management of contracted resources is required; site monitoring and clinical quality compliance experience is preferred.

- Advanced knowledge and understanding of the principles of Good Clinical Practice.

- Advanced knowledge of drug development process and clinical study phases.

- Proven Project Management skills (planning, timelines, tracking and reporting).

- Advanced knowledge of Microsoft Office

- Experience in clinical trial authorisation approval processes.

- Knowledge of software systems EDC, CTMS and eTMF.

- Experienced in the management of CRAs, Clinical Operations personnel and other Project Managers.

- Ability to communicate effectively in a second European language is advantageous.

- Valid drivers' license.