Company: Novella Clinical Resourcing
Location: Stevenage, Hertfordshire
Reference: NC- ISSCMAN 1622327
Closing Date: 09 Dec 16
Type: Full Time
Salary (£): On Application
Benefits: Include bonus, health insurance, life assurance, pension etc
Line manager with good experience of clinical research and/or document management required for office based role with Novella in Stevenage.
Novella Clinical, a Quintiles company, has a vacancy for an ISSC Manager, (Study Start Up). The ISSC 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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