Company Name: Novella Clinical
Channel: Clinical Research
Location(s): Europe, England, Cambridgeshire
Europe, England, Hertfordshire
Europe, England, London
Function(s): Clinical Research, Clinical Project Manager
Salary: ??
Benefits: Full benefits package
Position Type: Permanent
Ref. Code: NOCPMBOR
Clinical Project Manager
Job Summary:
Excellent opportunity to work as a Clinical Project Manager in Cambridgeshire offices for a leading CRO within the early phases.
Requirements:
Clinical Project Manger (CPM, CRO, Perm, Cambridgeshire)
Our Client
Our client, a leading CRO based in Cambridgeshire, are specialists within the early clinical trial phases and work as an enthusiastic, motivated and service-orientated team, where honest communication is key.
Role
To manage the project team to deliver protocol specific deliverables according to regulatory requirements and within the agreed time schedules.
Main Responsibilities
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To manage ongoing clinical studies and the clinical project team on a day-to-day basis.
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Responsible, with the Principal Investigator (PI), for decision making within the boundaries specified by the clinical protocol and in accordance with SOPs.
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Line/performance management of CTCs.
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Primary contact with the Sponsor and other external collaborators, unless agreed otherwise.
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To plan and manage the trial schedule including resource planning.
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To oversee all project related activity including:
- investigator file
- trial documentation and amendments
- EC and MHRA submission
- drug and sample labels
- ICFs
- volunteer recruitment
- clinical paperwork
- clinical unit set-up
- screening and clinical phase (IMP, QP release, stores order, catering requirements)
- sample management (processing, storage and shipping)
- laboratory analysis including biomarkers
- laboratory data extracts
- subject participation logs
- PI delegation logs
- data management including internal CRF QC
- data query resolution
- archiving
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Review of trial documentation.
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To prepare and deliver trial specific training.
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To carry out clinical tasks as delegated by the PI, in line with areas of competence and training.
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To manage all external service providers to ensure delivery of quality data/service to schedule.
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Attendance at safety review meeting.
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Maintain a thorough knowledge of regulatory requirements for the conduct of clinical trials.
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Financial management of clinical studies.
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To manage clinical protocol non-compliance and quality incidents
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To identify cross project, cross-functional, timeline and cost issues.
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To initiate new procedures and improvements to existing processes to maximise the efficiency of the role and the quality of deliverables to the sponsor.
Employees reporting to the Job Holder
Clinical Trial Coordinators
Decision Making Authority
Decisions relating to all aspects of the organisation of early phase clinical trials in accordance with protocol and regulatory guidelines to ensure the smooth running of the trial and meet trial deadlines.
Development and implementation of recommendations to improve working methods, equipment and supplies to ensure the smooth running of each clinical trial.
Line and performance management of CTCs.
Accountable to the Clinical Research Management Team.
Job Challenges
Leading a number of different clinical trials at the same time, ensuring that all requirements are delivered to time and the expected level of quality.
Managing sponsor expectations during the performance of each clinical trial.
Main duties / responsibilities of the Clinical Project Manager
Qualifications and experience required:
EDUCATION/PROFESSIONAL EXPERIENCE
Relevant scientific degree and/or nursing qualification. Three years experience in Clinical Research related role with sound knowledge of early phase clinical trials processes.
SKILLS & COMPETENCIES
• Results oriented team player, with excellent communication skills, who can work to deadlines, is flexible and enjoys a dynamic team environment.
• Efficient, effective and timely written and verbal communications skills.
• Interpersonal skills include the ability to deal with different types of internal/external customer and internal contact to meet project objectives in the most effective and efficient way, maintaining excellent relationships for the long term.
• Ability to adapt communication skills to all levels of staff.
• Demonstrates well-developed leadership skills and the ability to ‘see the bigger picture’.
• Remains focused, positive and adaptable to unexpected demands.
• Show tenacity and determination in completion of tasks.
• Performs in an organised, accurate and methodical manner.
• Ability to identify and resolve problem/issues.
• Ability to perform presentations of trial related information.
• Understanding of Clinical Research business and associated processes and procedures.
• Ability to work within a structured business environment with strict regulatory control.
Skills and aptitude required
Must have good written and oral communication skills
Good negotiation and presentation skills
Team player but ability to work under their own initiative
Able to form strong cross-functional relationships, demonstrating an ability to influence/persuade others
Flexible
Proactive
Ability to cope under pressure
Critical assessor/ good eye for detail
Organised
Innovative
Self starter
