Company: Novella Clinical Resourcing
Location: Stevenage, Herts
Closing Date: 30 Jan 17
Salary (£): 30,000 - 40,000
Benefits: Includes pension, bonus, life and health insurance.
Line management opportunity in Study Start Up group at expanding global CRO, part of the Quintiles group of companies. Requires prior line management/team leadership experience, good knowledge of study start up activities and strong ICH-GCP knowledge.
Novella Clinical, a Quintiles company, has a vacancy for an ISSC Manager, (Site Start Up). The ISSC (Investigator Strategy & Site Coordination) department is responsible for the quality and regulatory compliance of the Principal Investigator credentialing, essential documents and investigator site files process at Novella.
Essential job functions include:
• Responsible for direct line management for ISSC team members including resource selection and hiring performance training and oversight, timesheet review and approval and team collaboration activities.
• Leads Start Up activities and updates during weekly client teleconferences and internal team meetings.
• Interacts with sponsors, clinical and contracts teams to prioritize sites to be focused on for activation.
• Leads the development of site qualification questionnaires and protocol review, drawing on medical knowledge and regulatory expertise, to interview sites for potential involvement in studies or trials.
• Directs the creation and dissemination of Confidential Disclosure Agreements (CDAs) and Feasibility Questionnaires to sites and follows up accordingly to determine interest and to meet study timelines.
• Negotiates the CDA on behalf of sponsor according to country requirements.
• Oversees the negotiation of Informed Consent Forms.
• Leads a team as they assist sites with local IRB/ethics committee submissions
• Leads the start up team in creation of templates for regulatory documents specific to local and central Institutional Review Board (IRB) / ethics committee submissions. Oversees/leads in the assembly and distribution of regulatory documents to sites and/or assembles and distributes regulatory documents as the need arises.
• Notifies Regulatory Affairs department and/or assures team members notify Regulatory Affairs when initial essential documents are available for review. Works with Regulatory Department to resolve any concerns.
• Manages quality and regulatory compliance documentation among investigational sites.
• Manages study timelines, documents study challenges and communicates them to the, Sr. Mgr. or Associate Dir. and Project Manager.
Knowledge, skills and abilities required:
• Demonstrated ability in the leadership of a team of individuals in the start up type process activities.
• Knowledge of clinical research process and medical terminology.
• Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members.
• Excellent organizational and interpersonal skills.
• Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
• Ability to manage multiple competing priorities within various clinical trials.
• Working knowledge of current ICH GCP guidelines and applicable regulations.
• Ability to reason independently, assess and recommend specific solutions in clinical settings, and mentor staff.
This is a full time, permanent role, initially office based in Stevenage, Hertfordshire but some home working may be possible at a later date. It offers a competitive salary and benefits package.
Key words – study start up, study start up manager, line manager, document management manager, document manager,
Novella Clinical Resourcing
Ground Floor, Abel Smith House, Gunnells Wood Road, Stevenage, Hertfordshire
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