Clinical Study Manager

Expiring today

Recruiter
Chiltern
Location
Berkshire
Posted
23 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Job Background The Company is officially certified by the Top Employers Institute for its exceptional employee offerings for the fourth consecutive year, and for the first time, Top European Employer Wide Therapy Area Coverage within General Medicine and Oncology Competitive salary and benefits Full support and a focus on development Free access to training Great team of people Would suit a career study manager who wants an office/home based role with no monitoring/minimal travel. We will consider 4 days/week or full time Permanent employment with Chiltern - seconded to a top ten pharmaceutical company 12 Months rolling contract PAYE salary and a wide range of company benefits PLEASE NOTE - You would need to be based in OFFICE at Junction 4 of the M3 - THREE DAYS/WEEK 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 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. Salary is competitive plus 25 days leave, car or car allowance, pension, LI, gym subscription membership contribution, and other pastoral benefits. 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. Major accountabilities of the CSM Recognize potential challenge within the protocol and operational aspects of the trial and escalate to manager as appropriate. 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 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 5+ 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 Salary On Application Position Type Permanent Full Time or Part Time Contact Email Marc Joseph - marc.joseph@chiltern.com 01753 216664

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