Company: Barrington James Clinical
Closing Date: 09 Feb 17
Salary (£): Competitive
Exciting opportunity to work for a small Biotech based in Sweden!
Clinical Study Manager - IMMEDIATE START!
The Clinical Study Manager (CSM) will be responsible for the operational planning and oversight of delivery of early phase clinical trials normally conducted by an experienced full service CRO.
These studies are expected to be Phase 1 or Phase 2a/2b conducted in Scandinavia.
The CSM will work closely with the Head of Clinical Operations and other in-house cross-functional experts such as Discovery or Tech teams.
Responsibilities include the evaluation, selection, and management of CROs and other Vendors to plan and deliver individual studies. Vendors may include providers of Clinical Trial Supplies, or specialist evaluation expertise.
The CSM will be responsible for day to day interactions, issue management, and general guidance working with senior CRO and/or Vendor staff (ie Clinical Data Management, Biostatistics, Regulatory/QA, Pharmacology, Biology) and to interact and visit investigator sites, as required.
This individual will report into the Head of Clinical Operations.
This is a freelance position, located in Stockholm, Sweden.
• Oversee performance of CROs, and other third party vendors, including co-monitoring, to ensure delivery of quality data on time, compliance with study protocol, and regulatory and safety compliance
• Identify areas requiring action, and escalate to CRO managers, and Head of Clinical Operations, as appropriate
• Develop and maintain good visibility/motivating relationships with investigators and study staff
• Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study- specific manuals and procedures
• Provide Internal Sponsor reports of progress of each study including site activation, patient enrollment, costs, issue resolution.
• Oversight of investigational product (IP) supply, and CRO accountability and reconciliation process of material.
• Review or contribute to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related regulatory documents
• Support Regulatory activities and document production.
Five to eight years Clinical Operations work experience in the pharmaceutical industry and working knowledge of GCP/ICH guidelines and the clinical development process.
• Experience working with and managing vendors, including performance assessments, financial management (invoice review, change order management, budget reforecasting, etc.) and senior manager interactions required.
• Strong interpersonal, communication (electronic and verbal), and organizational skills
• Demonstrated ability to work independently as well as part of a Sponsor/Vendor study team
• Able to solve problems under pressure
• Self-motivated and able to work effectively in dynamic start-up environment
• Availability for potential travel local.
• Must enjoy working in a high responsibility, motivated, small company environment
This is an exciting opportunity to join a Swedish based biotech company.
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