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Job Details

Clinical Research Manager - Turkey - Permanent Contract - Office based Opportunity

Company: Clintec
Location:
Reference: TURKEY-CRM-060818-LT
Closing Date: 15 Nov 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Clintec is actively recruiting for a Clinical Research Manager to join our expanding global company in Turkey – this is a Permanent Office based opportunity. The successful candidate will work fully assigned to one of our sponsors, a top 5 pharmaceutical company. This role is primarily accountable for the end to end performance for assigned protocols in a country.

Requirements:

Clintec is actively recruiting for a Clinical Research Manager to join our expanding global company in Turkey – this is a Permanent Office based opportunity. The successful candidate will work fully assigned to one of our sponsors, a top 5 pharmaceutical company. By working for Clintec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.

 

This role is primarily accountable for the end to end performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, compny policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Main responsibilities:

  • Main Point of Contact (POC) for assigned protocols and link between Country Operations (CO) and  clinical trial team (CTT).
  • Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
  • Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally
  • Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed
  • Performs Quality control visits as required
  • Leads local study teams to high performance: trains in the protocol other local roles,  closely collaborates with and supports CRAs as protocol expert  and coordinates activities across the different local country roles ensuring a strong collaboration
  • Responsible for creating and executing a local risk management plan for  assigned studies
  • Ensures compliance with CTMS, eTMF and other key systems in assigned studies
  • Escalates as needed different challenges and issues to TA director/CRD/CQM and or CTT (as appropriate)
  • Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies 
  • Country POC for programmatically outsourced trials for assigned protocols.
  • Serves local business needs as applicable in his/her country(If delegated can sign contracts and  manage budgets)
  • Collaborates internally with HQ functions and locally with PV, Regulatory and GMA to align on key decisions in his/her studies.  
  • As a customer-facing role, this position will build business relationships and represent company with investigators
  • Shares protocol-specific information and best practices across countries\clusters

? Educational Requirements:

Required:

  • Bachelor’s degree in science (or comparable)

Preferred:

  • Advanced degree, (e.g., Master degree, MD, PhD)

Experience Requirements:

Required:

  • Strong Clinical Research Experience including previous CRA experience
  • Knowledge in Project/Site Management.
  • Strong organizational skills with demonstrated success required.
  • Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments
  • Requires strong understanding of local regulatory environment
  • Strong scientific and clinical research knowledge is required
  • Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
  • Strong leadership skills
  • Ability to identify problems, conflicts and opportunities early and lead, analyse and prepare mitigation plans and drive conflict resolution is critical.
  • Required to negotiate skilfully in tough situations with both internal and external groups; settle differences with minimum noise  
  • Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other external stakeholders

Apply for this job: Clinical Research Manager  - Turkey - Permanent Contract - Office based Opportunity

Contact Information:

Address:  Head Office
Clintec International Ltd,
133 Finnieston Street,
Glasgow
G3 8HB
Scotland
Reasons to work for Clintec
Tel:  +44 (0) 141 226 1120
Fax:  +44 (0) 141 248 8993
Website:  Visit Our Web Site

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