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Job Details

Clinical Study Manager - Contract Home Based

Company: ProClinical Ltd
Location: United Kingdom
Reference: CR.MP.14308
Closing Date: 23 Nov 17
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

ProClinical is seeking a contract Global Clinical Study Manager for a small emerging biopharmaceutical company specialising in rare diseases to be UK homebased. Job Responsibilities: Manage clinical study/studies according to global regulatory requirements (including but not limited to US CFR, EU CTD, and ICH GCP) and company SOPs, and supporting clinical strategy defined in Clinical Study Plan (CSP). ...

Requirements:

ProClinical is seeking a contract Global Clinical Study Manager for a small emerging biopharmaceutical company specialising in rare diseases to be UK homebased. 

Job Responsibilities:

  • Manage clinical study/studies according to global regulatory requirements (including but not limited to US CFR, EU CTD, and ICH GCP) and company SOPs, and supporting clinical strategy defined in Clinical Study Plan (CSP).
  • Lead cross functional Study Execution Team, including company functions, Strategic Partners and other vendors to ensure study goals are met, on time and within budget. Includes leading and organizing cross functional study team meetings.
  • Ensure appropriate regional input for global or multinational studies prior to decision making. Responsible for communication of study information to Clinical Operations regions.
  • Contributes to protocol synopsis development and to Clinical Study Plan development, including Clinical Operations feasibility assessments.
  • Leads the cross functional protocol development process, including responsibility for any protocol amendments or administrative changes.
  • Management of Strategic Partners, including setting expectations, training, CRO Oversight process, Task Orders, Change Orders, invoice approval and financial reconciliation process for assigned study. Responsible as the company’s first point of contact for Issue Management process for assigned study. (Range: $750,000 (e.g. less complex Phase 1) to $250 million (large complex outcomes studies))
  • Leads the evaluation and selection of required vendors, including contract and budget negotiation, invoice approval and financial reconciliation process.
  • Responsible for day-to-day management of vendors working on assigned study, including setting expectations, training, managing timelines and deliverables, and issue management.
  • Provides Clinical Operations input to other important study activities, including but not limited to: site identification and selection, enrolment models, clinical supply planning and drug supply, organization of investigator and vendor meetings, development of informed consents forms, planning and management of Trial Master File, development of monitoring plans, development of IxRS systems, development of EDC / Case Report Forms, review of data during the study, data cleaning and database lock, writing the Clinical Study Report.
  • Escalates medical issues to appropriate medical personnel.
  • Provides regular budget updates to Clinical Program Manager, or Finance when required.
  • In collaboration with Study Execution Team (company functions, Strategic Partners, and vendors), identify risks to study and develop risk mitigation plans, including communication and collaboration with Clinical Program Manager and Associate Director, Clinical Operations to escalate risks and ensure rigorous risk mitigation planning.
  • May be asked to participate in issue management and risk mitigation for studies assigned to other Study Managers.
  • Able to assist in role of Clinical Program Manager and may represent Clinical Program Manager, when necessary
  • Leads or provides expert input for Clinical Operations or cross functional initiatives

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Pike on +44 207 4400 639 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. 

Apply for this job: Clinical Study Manager - Contract Home Based

Contact Information:

Address:  ProClinical Ltd
Eldon House Eldon Street London
EC2M 7LS
England
Tel:  0800 988 4437
Fax:  +44 (0)207 834 9470
Website:  Visit Our Web Site

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