Closing Date: 13 Mar 17
Salary (£): Competitive
This is a "classic" clinical project management position - a mix of office and home based (the office is in Camberley) working in a dynamic UK Clinical Operations Group across general medicine (excluding Oncology) The actual job title within the pharma company is Clinical Study Manager (CSM)
It is a full time clinical project management opportunity - mix of home based and office based (office is junction 4 off the M3). You would need to be within a reasonable commute of Frimley Business Park in Camberley.
We have a strong strategic alliance with our pharma partner and you would be joining a team of Chiltern clinical operations "contract personnel" within their UK and Ireland Operations group.
We are looking for a DYNAMIC Clinical Project Manager – someone who is interested in career development and appreciates the benefits of being “employed” rather than freelance.
This is NOT a freelance role.
You would be employed permanently by Chiltern and seconded to our client.
You will receive full support in terms of line management/pastoral care, full administrative support, and access to both soft skills and technical advancement courses. We need someone who will commit and build a strong relationship within our strategic partnership.
Reporting to the clinical study team leader, the local study manager is accountable for planning, executing and reporting on a number of phase I-III and global phase IV clinical studies for a country, from planning and site feasibility through study close-out, in compliance with processes and regulatory requirements.
This role is a CLASSIC Clinical Project Management position and as such we need a seasoned candidate - someone with around 2 years CPM level exposure.
The role will start as soon as possible allowing for notice periods of course.
Major accountabilities of the CSM
Recognize potential challenge within the protocol and operational aspects of the trial and escalate to manager as appropriate/decide on appropriate action.
Independently collect and manage input to protocol, and operational aspects of the trial.
Maintain a strong knowledge of the protocol to be able to answer standard operational questions from monitors, sites, and local internal personnel.
In liaison with the global clinical team, assist in the development of/independently lead strategic local trial execution plan and timeline commitments for a country.
Ensure that study start-up activities and any amendments are conducted and completed on time, including preparation of IRB/EC submission packages, working with regulatory affairs for Health Authorities submissions.
Monitor the status of site budget and contract negotiations as well as the collection and review of essential documents.
Coordinate and manage the site selection process in collaboration with the necessary line units.
Ensure sites are prepared for “Ready to Initiate Site” (checkpoint). Obtain written confirmation about availability of global documents.
Ensure that all documentation in place for initial and subsequent drug release in collaboration with the local Qualified Person.
Provide training as needed for monitors and any other activities that support site readiness to recruit.
Ensure documentation of training (global/regional/local IM minutes, participants’ lists, certificates, etc.) is archived appropriately.
Drive the conduct of the trial, track and oversee progress and status.
Ensure all operational aspects are on schedule.
Oversee local clinical team activities to achieve trial timelines and quality execution according to standards and local and international regulations.
Consistently read/review the content of all monitoring visit reports for the assigned trial to identify trends and issues. Appropriately escalate issues in a timely manner and ensure resolution.
Communicate with field monitors on a regular basis to assure proper adherence to protocol, timelines and other trial related topics.
Lead and chair local study team meetings, attend and participate in global clinical trial team meetings.
Track trial budget with appropriate trial budget responsible in country. Oversee
TCF preparation and submission to COM.
Keep oversight of country level data management activities, including timely resolution of data entry issues, screen failure reasons, discontinuation rates, patient profiles, and proactively identify data entry issues to mitigate queries.
Accountable to keep reporting systems up to date: ClinAdmin, TMF, CREDI throughout trial conduct.
Ensure that all trial close–out activities are performed, in close cooperation with field monitors and clinical trial head.
Oversee local vendor selection and performance as needed. Serve as main contact for any potentially significant quality/compliance issues and escalate to clinical trial team as required.
Facilitate internal audits and HA inspections as required.
Conduct local investigator meetings as needed.
Works with Quality Manager to ensure that all clinical trial related activities adhere to the requirements of current UK/EU legislation
Acts as a Clinical Trial Head (CTH) for local phase IV studies:
Assumes global study management responsibility for the management of local phase IV studies in the UK to target, timelines and within budget.
Contributes to the design/writing of UK study protocols, reports and publications within agreed timelines and budget.
Liaises with Global to post local Phase IV studies on Registration and Publication databases.
Develops and maintains relationships with Key Opinion Leaders (KOLs).
Completes Site Specific Worksheets (SSWs) for globally outsourced studies and is the main point of contact for the global team and CRO regarding UK management.
Shares best practice openly and constructively with Clinical Study/Project Managers – acts s a project management role model.
Degree in scientific of healthcare discipline. Master degree preferred
Languages: English written and spoken
Requirements: ideally 7+ years pharmaceutical industry experience with 5 years’ strong experience in clinical research
Experience in a monitor role or a role overseeing clinical trials
Strong Interpersonal skills
Strong Project Management skills
Working experience in a global team, team player
Ability to work under pressure
Please call Marc Joseph on 01753 216664 for further discussion about the role OR send your CV and covering letter directly to Marc.firstname.lastname@example.org
key words clinical project manager, clinical study manager, clinical project management, clinical study management, CPM, CSM,
171 Bath Road Slough Berkshire
SL1 4AA, UK
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