Cambridge Cognition are looking for an organised and team-oriented individual to join their Study Management Team.
Summary of Role:
Responsible for the set-up, delivery and management of projects which include Cambridge Cognition’s neuropsychological tests and/or electronic scales and questionnaires (deployed electronically via the CC platform) for use in clinical trials.
This key role in the Study Management within the Cambridge Cognition (CC) Operations team includes but is not limited to:
- Manage the overall process of planning, scheduling and execution of a contracted project from contract finalisation (handover from Sales) to database lock/contract completion to ensure optimal delivery of the project as per the client’s specified requirements
- Represent CC at clients’ project meetings - often international meetings with other vendors present
- Ensure a high level of customer support for any inbound client, site or co-vendor enquiries
- Manage budgets and deliverables across multiple projects for assigned projects, including the change order process when project / scope of services requires amendment post contract execution
- Provide input to and review contract proposals, as required
- Track and report project milestones and maintain relevant internal systems with project specific information
- Evaluate departmental processes and drive continuous improvement
- Ensure client correspondence and documentation is maintained in appropriate internal systems, including trial master files
Clinical Trial Knowledge and Expertise
- Conduct project in accordance with GCP and all relevant clinical trial regulations
- Ensure all aspects of the project complies with CC’s SOPs and all Quality Management requirements are fulfilled, including ISO9001 and data privacy
- Ability to review and interpret a client’s study protocol and provide any pertinent feedback which may impact the use of CC’s products as part of the clinical trial
- Use search tools to understand any scales, questionnaires and associated licences, and translations required as part of the contract
Technology / Software Deployment
- Liaise with Logistics team within Operations to supply hardware to site(s) in line with study timelines as well as any return or site re-deployment and maintain appropriate records
- Drafting or review and sign-off study related documents e.g., URS, DMP
- Configure CANTAB Connect Data Capture Software to client’s specification using the CANTAB Connect configuration tool.
- Coordinate the preparation of CANTAB Connect configuration for testing and release to sites
- Ensure licence approval and any required translations applicable to scale/questionnaire deployment are completed as required and per timelines
- Train site personnel to administer the CC products as required (this may include travelling to investigator meetings and clinical trial sites, as well as providing on- line training)
- Oversee preparation of study specific on-line training program (LMS) where applicable ensuring all appropriate client reviews are completed
- Communicate with sites and/or client to resolve issues related to test administration failure
- Provide feedback to the Product and Software teams internally to correct faults and optimise operational efficiency
Note: The above is not an exhaustive list and responsibilities may vary dependant on the need of the role and the business.
Qualifications and Experience:
- BSc in Psychology or related discipline or demonstrable experience in a similar role
- Knowledge of GCP and clinical trial regulations
- Exemplary communication skills, both verbal and written, including being a confident presenter
- Excellent inter-personal skills across a range of stakeholders and experience of working successfully as part of a team
- Interest and aptitude for using technology and problem solving
- Well-honed organisational skills including attention to detail and ability to handle multiple projects independently
- Experience of the pharmaceutical/biotech industry and clinical trials or neuropsychological testing would be an advantage
- Experience of project management
- Experience using digital technology / software
- Working knowledge of ISO 9001
Cambridge Cognition offers an excellent benefits package and salary commensurate with experience. Applicants must have the right to work in the UK. The position will remain open until filled.
Once an offer of employment has been accepted, the successful candidate will be required to undergo a basic disclosure (criminal records check) check and a security check.
Cambridge Cognition is an equal opportunities employer, we are committed to equality of opportunity for all employees and application from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief, marriage and civil partnerships