Clinical Project Manager
Job Type: Full-time, Permanent
Hours: Full time
Job Types: Full-time, Permanent
As a Clinical Project Manager in Ultromics, you will play a key role helping to support the expansion in the company’s clinical research programme. The Clinical Project Manager will be responsible for the co-ordination of the clinical studies, working with the other members of the clinical research team and the sites to ensure the successful delivery of the studies. The role will combine facilitation of research protocol design; coordination of the smooth running of the clinical research studies; data management; record keeping; coordinating the Trial Steering Committee meetings and training junior members of the clinical research team. Excellent leadership and communication skills, as well as a high degree of organisational ability are key.
Key Duties & Responsibilities
a) Project coordination and management
- Independently develop, manage, and execute the project plan and timelines for deliverables.
- Oversee the study teams to ensure timely and effective completion of project assignments; Ensure the timely recruitment of trial participants.
- Establishment of procedures to ensure adherence to protocols and administrative requirements.
- Work with the Clinical Research team on audits and monitoring of the research studies to ensure compliance with and adherence to quality standards, SOPs, ICH-GCP and/or other guidelines and to identify, evaluate and rectify problems.
- Work with the Head of R&D to ensure that the project is meeting its targets, is producing meaningful output and to predict and plan any changes in the protocol, funding or timelines.
- Plan and support regular project meetings and work of the various stakeholders, groups and bodies associated with the project.
- Work with the Clinical Research team to develop ethics applications, protocol amendments, submissions to the regulatory authority, and NHS Research and Development bodies.
- Maintain proper financial records of all project expenses and oversee their payment by liaising with the finance team; ensure the project is completed within budget, schedule and according to contract specifications.
- Coordinate Trial Steering Meetings and statistical support for the projects.
- To take responsibility for study set up and activation: ensure appropriate sites are identified; establish links with key members of the study teams; ensure essential documentation is in place at each participating site.
b) Communications and networking
- Manage and co-ordinate all internal and external project communication.
- Co-ordinate the preparation and publication of data, reports and information, ensuring that these meet legislative, contractual and ethical requirements.
- To ensure clear and effective communication is maintained with the recruiting sites, monitoring targets, providing feedback and ensuring support is provided where necessary for the staff in those sites to promote good relationships.
- Play a leading role interacting with IT colleagues for planning and deployment of IT and data management processes.
- Interact with University, NHS Trust and healthcare providers research governance teams.
c) Clinical Research Team activities
- Lead the evaluation of project activities, ensuring that lessons learned are integrated into future proposals.
- Assist with recruitment, training and supervision of Clinical Research team members as appropriate.
- Report to appropriate Line Managers any anticipated need for additional resources and any needs or concerns regarding level of training or performance.
- Work with the Clinical Data Manager to develop Data Management Plan; manage the designing and testing of new trial databases.
- This list of duties is not exhaustive and the post holder may be asked to carry out other duties through discussion with their line manager.
- Primary Degree in a scientific or technical discipline or equivalent experience
Evidence by certificates
Skills, knowledge & experience
- Comprehensive knowledge of life sciences; experience in clinical cardiovascular disease area.
- Previous experience or knowledge of coordinating multi centred National/ International clinical trials.
- Previous experience or knowledge of a commercial research environment.
- Experience of supervising/mentoring staff.
Evidences by application/interview/references
Willingness to travel within the UK
Evidenced by application/interview
We are an equal opportunities employer and positively encourage applications from suitably qualified and eligible candidates. Entry into employment and progression within employment will be determined only by personal merit and the application of criteria which are related to the duties of each particular post and the relevant salary structure. In all cases, ability to perform the job will be the primary consideration. No applicant or member of staff shall be discriminated against because of age, disability, gender reassignment, marriage or civil partnership, pregnancy or maternity, race, religion or belief, sex, or sexual orientation.
If you’re selected for an interview and have special requirements due to a disability please let us know so that we can make any necessary adjustments.
Information Security Compliance
By applying for this position you are confirming that you will read, understand and comply with the Company’s Information Security Policies if you are hired for this role.
How to Apply
Fill in the form below, making sure you attach the following:
1) Your CV
2) A document detailing how you meet the role requirements and explaining why you are applying for the role.
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