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Job Details
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Senior Clinical Trial Manager



Business Type: Biotechnology Company, Clinical Research Organisation
Job Type: Clinical Study- Trials
Job Level: Experienced (non manager)
Position: Full Time
Location: Switzerland
Reference: STMM80
Closing Date: 14/08/17
Background:
Position: Senior Clinical Trials Manager
Location: Switzerland ( Relocation assistance provided by the client)
Contract type: Fulltime permanent

Position Summary
A Senior Clinical Trial Manager position is available with a global pharmaceutical company specialised in the therapeutic area of Oncology besides Haematology and Immunology.
The Clinical Trial Manager executes clinical trials from moderate to high complexity (in terms of design, location, phase, etc.). Proactively identifies and resolves clinical project issues and participates in process improvement initiatives as required.


Primary Responsibilities:

*Manages all clinical aspects of a clinical study, including: assesses operational feasibility and recommends study execution plan; manages study timelines and metrics; provides study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel; prepares and presents project debriefings, as required; plans, executes, and attends/manages study-specific meetings (e.g., Study Management Meetings, investigator meetings, etc.) as applicable.
*Serves as main point of contact for sites within Clinical Operations department; works with CRO to select countries and sites for trial participation; develops relationships with investigators and site staff; coordinates and assists in the planning of regulatory or ethics committee activities, as appropriate; participates in selection, management and oversight of external vendors and develops vendor specifications; reviews vendor reports, budgets, and metrics.
*Uses operational and therapeutic expertise to optimize trial design and execution: works with the study team to design clinical trial protocols and manages review process; assists in developing/managing an ongoing data review plan to ensure detection of data trends and to ensure study objectives are met; prepares study-related documentation.
*Prepares and/or reviews study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Pharmacy Manual, and CRF Completion Guidelines, etc.); supports the creation of CRFs, etc.
*Prepares/reviews site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts/budgets, and site payments).
*Assists in the development and management of overall study budget and maintains it within financial goals; reviews and approves all study related invoices against approved budget.
*Manages clinical monitoring activities (including approval of visit report templates, monitoring plan, etc.) ensuring compliance with ICH/GCP and applicable regulations. Includes management through resolution of any site or study level issues, deviations, etc.
*Ensures all clinical trials are executed in compliance with ICH/GCP guidelines/regulations and applicable SOPs: participates in the planning of quality assurance activities and coordinates resolution of audit findings; ensures audit-ready condition of clinical trial documentation including central study files; reviews monitoring reports to ensure quality.
*Interfaces with cross-functional teams (e.g. Medical Monitor, Regulatory Affairs, CRO, vendors and Investigators/site staff).


Requirements:

Education:

Bachelor''s degree or equivalent combination of education/experience in science or health-related field required.

Professional Experience:

*Minimum of 4 + years of clinical trial management experience in a CRO/Pharmaceutical/Biotech environment required.
*Preferred - Global trial experience in Oncology.
*Strong understanding of ICH/GCP, and knowledge of regulatory requirements.
*Excellent communication and organizational skills, along with problem solving, conflict resolution, leadership and team-building skills.
*Works well within a team-centric environment.

For additional information please contact me on vamsi.gentela@secpharma.com or 0044(0)2072556638


SEC Pharma Posted by:: SEC Pharma (View all our vacancies)
Unless otherwise stated, if applying for a job, you must ensure that you are already authorised to work in the country in which the job is based
Posted: 17/07/2017 | NPJ Ref: 190660
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