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Job Details

Site Start Up (ISSC) Manager - Permanent. Office based Stevenage

Company: Novella Clinical Resourcing
Location: Stevenage, Herts
Reference: NC1622327-ISSCMan
Closing Date: 30 Jan 17
Type: Permanent
Salary (£): 30,000 - 40,000
Benefits: Includes pension, bonus, life and health insurance.

Job Summary:

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,

Apply for this job: Site Start Up (ISSC) Manager - Permanent. Office based Stevenage

Contact Information:

Address:  Novella Clinical Resourcing
Ground Floor, Abel Smith House, Gunnells Wood Road, Stevenage, Hertfordshire
Tel:  +44(0)1438 221122
Fax:  +44(0)870 762 6257
Website:  Visit Our Web Site

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