Study Management Associate - Cambridge

Recruiter
CK Clinical
Location
Cambridge
Salary
£200 to £250
Posted
02 Dec 2017
Closes
05 Jan 2018
Sector
Healthcare
Contract Type
Contract
Hours
Full Time
Lucy Stendall is recruiting for a Study Management Associate to join a company in the Pharmaceutical industry at their site based in Cambridge on a contract basis for 12 months initially.

The main purpose of the role will be:
- Coordinating and delivering the administrative Study Delivery (SD) activities within the Study Delivery Team (SDT) as required by each study, to ensure maintenance of relevant systems, and quality and consistency of SD deliverables to time, cost and quality objectives
- Comprehensive management and archiving of study documentation
- Proactive participation in the UK MC study team(s).
- Proactive management of all Administrative aspects of the set up and conduct of clinical trials within UK study sites, and delivery of the associated study milestones, targets and activities within the allocated resource/time
- Collaboration with the Clinical Project Leader, Clinical Administration Manager, other SDAs, Clinical Research Managers, and the Clinical Research Associates to ensure that quality and quantity commitments are achieved in a timely and efficient manner

Further responsibilities will include:
- Coordination of allocated aspects of study delivery operational activities for MCCD led R&D studies or MCCD led LCM studies, from SDC through database lock and study close-out activities including reporting
- Collaboration with the Clinical Project Leader, Clinical Administration Manager, other SDAs, Clinical Research Managers, and the Clinical Research Associates to ensure that quality and quantity commitments are achieved in a timely and efficient manner
- Maintain systems tracking sheets as required for allocated studies
- Where required, support the Clinical Project Leader by setting up the local Trial Master File (TMF) and ISF, including tracking of documents. Ensure that critical documents are maintained in the centre specific and general sections of TMF for allocated studies to required quality standards. Work with Clinical Project Leader to maintain the TMF index, and perform Quality & completeness check of essential documentation at specific study milestones to ensure TMF is inspection ready.
- Contribute to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e. Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities (not for international studies).
- Lead the practical and administrative arrangements and contribute to the preparation of internal and external meetings e.g. study team meetings, monitor meetings, Investigator meetings.
- Assist with the management of vendors
- Mentor and coach new Study Delivery Administrators- provide guidance and training on all applicable activities
- Close collaboration and role flexibility with CRA and CPLs for study delivery and individual development
- Support Clinical Administration Team colleagues to deliver unexpected or urgent business tasks, provide contingency cover for absences
- Support Clinical Administration Manager to provide continuity of logistical services for Clinical Operations
- Maintain knowledge of relevant clinical processes and SOPs to ensure appropriate compliance to ICH GCP/ABPI code of practice

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Level of education that supports Skills and Capabilities of the position and ensures successful conduct of accountabilities/responsibilities and appropriate interactions with internal/external customers. Qualification in Nursing, Degree or equivalent experience
- Relevant, proven administrative experience and organizational skills
- Proficient knowledge of Computer systems, Microsoft Office including MS Excel, computerised financial systems (SAP)
- Very good knowledge of spoken and written English
- Organised and efficient and with a strong ability for prioritising workload to deadlines

This is an excellent opportunity to join a leading multinational pharmaceutical company.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL40625 in all correspondence.