
09 Feb Clinical Project Manager
Clinical Project Manager
Operations · Bottisham, England, United Kingdom · Full time / Permanent
Department: Operations
Reporting to: Julie-Ann Marshall, Clinical Project Director
People Manager? No
Location: Bottisham, Cambridge
Contract: Permanent
Working pattern: Full time
Who are Cambridge Cognition and what do we do?
Our mission is to improve patient outcomes by providing the technology to better understand, detect and treat conditions affecting brain health. Our scientifically validated, gold standard portfolio of digital health solutions provide effective and efficient assessments of cognition and other markers of brain health. We are constantly innovating, researching, and developing new products and services to suit the needs of our academic and commercial clients. Our high-quality service ensures that our customers are fully supported throughout their experience with us. Our success in commercialising existing products together with increasing demand in the sector is driving rapid growth. We are looking for exceptional candidates to join our team at this exciting time as we continue to invest for future growth.
What you’ll do
This is an exciting, key role within our Clinical Project Management team. We’re looking for a Clinical Project Manager (CPM) to join our team. You’ll manage the delivery and execution of our neuropsychological testing projects for pharmaceutical clinical trials.
The role can be broken down in to 3 keys areas of responsibility:
Project Management
- 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 Cambridge Cognition at client 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
\What we’d love from you
- BSc in Psychology or related discipline or equivalent or demonstrable experience in a similar role
- Knowledge of GCP and clinical trial regulations
- A team player, willing to learn, problem solve and support others
- Exemplary communication skills, both verbal and written, with strong presentation skills
- Confident in presenting to clients, and manage multiple projects
- Excellent inter-personal skills across a range of stakeholders and experience of working successfully as part of a team
- An 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, working across multiple platforms and systems
- Experience of project management would be preferred
- Experience using digital technology/software and working knowledge of ISO 9001 would be ideal
What we can offer you
- Flexibility – our head office in the UK is in Bottisham, Cambridge; we work a hybrid model of 2 days in the office and the rest from home
- 26 days annual leave per year plus bank holidays
- Generous pension with up to 6.5% company contribution
- Life assurance 2x base salary
- Employee Assistance Programme (EAP)
- Private Health Insurance – Bupa Insurance, Simply Health Cashback Scheme
- Share options
Even if you don’t have all the experience we’ve listed we’d still love to hear from you if you’re interested.
We’re not currently able to sponsor employees. This means we’re unable to consider applications from candidates who are not eligible to work in the country our roles are based.
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.
Please click here to apply.
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