Skip to main content

This job has expired

Senior Clinical Project Manager

Employer
Barrington James
Location
South East England
Salary
Competitive
Start date
9 Oct 2019
Closing date
8 Nov 2019

Job Details

Are the following important for you?

- Work Life Balance

- Team Culture

- Career Development/Progression

- Making A Difference

I am currently partnered with a groundbreaking full service CRO providing Phase I-IV clinical development services to the biotechnology & pharmaceutical industries.

This particular client has seen exponential growth over the past 10 years and is looking for a driven individual to assist with the growth plans for the next decade.

This position is an exciting opportunity for someone who has existing experience in management within a CRO environment. You will be responsible for the delivery of day-to-day management of complex Oncology projects within the clinical operations department. 

The position has the flexibility of home or office based, there is a small requirement to be in the office once a week (or more if desired).

Non negotiable requirements for the role:

- Oncology background 

- CRO exposure 

- Project Management experience 

- Vendor management experience

- Science Graduate

Responsibilities include:

·Manage all operational aspects for implementation of clinical trial activities from study start-up through database lock, as required

·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 & Drug Safety, Medical Affairs and Clinical Operations staff to ensure timely, high quality and profitable delivery of projects

·Act as clients’ first point of contact– particularly with regard to the progress of the projects unless otherwise agreed. Maintain regular contact with clients by means of regular visits or TCs

·Keep and maintain records on the projects, coordinate meetings and TCs, circulate contact reports, raise purchase orders, track invoices and overall project progress

·Manage study-related vendors and serve as the primary point of contact for contractors as applicable identifying potential risks and resolving issues; conduct vendor selection and/or competency assessment

·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

·Coordinate the negotiation of site budgets within guidelines, and provide oversight for site payments per contracts

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

·Review monitoring reports, protocol deviations and data listings for allocated studies to ensure reliable quality data are delivered; coordinating with Sponsor on site selection, IRB submissions, site initiation and close-out planning

·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

·Identify any out of scope activities and report to VP, Clinical Operations or designee and the Contracts and Proposals Department.

·Research subject and business areas in order to maintain a comprehensive understanding of the client’s evolving objectives and ambitions for their products

·Be alert for possible new business opportunities and deal efficiently with any request for additional projects or services from clients. Liaise with the project director and other senior staff to develop proposals and budgets for these projects

·Work closely with Business Development personnel in identifying new clients and assist with the preparation of business proposals. Participate in bid defence meetings as required.

If you would like to learn more about this opportunity then please reach out to me by email.

Alex Smith - asmith@barringtonjames.com

Company

We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.

Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.

Company info
Website
Telephone
01293 776644
Location
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
GB

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert