- Oversees all aspects of clinical trial execution and delivery (timelines, budget, quality data and day to day operations) from protocol design to the final clinical study report.
- Ensures adherence of the clinical study to GCP, regulatory requirements and overall clinical objectives
- Chairs the cross functional Study Team Meetings ensuring identification and documentation of actions, decisions and risks.
- Trains the cross-functional study team on protocols, study documentation and procedures as appropriate
- Manages and maintains trial master file (TMF), including period reviews and ensuring TMF up to date, contemporaneous and inspection ready
- Actively involvement and coordination of development of protocols, Investigator Brochures, scientific review of clinical data, and study data analysis, reporting and publishing
- Selects manages and oversees clinical study vendors / CROs, including preparation of recommendations for the selection a (i.e. RFP, bid requests, proposal reviews, bid defence meetings, budget negotiations and contract development) generates and ensures adherence to vendor management plans
- Provides expertise and leadership in preparation and submission of ethics and regulatory submission forms
- Designs study materials (for example but not restricted to: information sheets, informed consent forms, CRFs, feasibility questionnaires, site training materials)
- Is involved in the development of specifications and user acceptance testing of key trial tools e.g. laboratory, eCRF, IXRS
- Ensures all relevant study approvals are obtained, reviews and confirms green light package is complete authorising site activation
- Follows ICH-GCP and FDA regulations and ensures GCP inspection-readiness
- Authorship and review of company SOPs
- Acts as a mentor to peers or more junior team members
- Bachelor's Degree in life sciences or related field and at least 7 years clinical research experience, including more than 5 years experience as a CRA (or equivalent).
- Ability to handle several important projects at the same time, juggling priorities and resources to meet company expectations and study requirements
- Excellent communication, written, interpersonal and presentation skills are required
- Regulatory and compliance knowledge, including Good Clinical Practice (GCP)
- Actively seeks out new learning experiences and puts the onus on self to self-develop and take ownership of responsibilities
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Clinical Project Manager - City of London, United Kingdom - Proclinical Staffing
Description
Job DescriptionClinical Project Manager / Senior Clinical Project Manager
As a Clinical Project Manager, you will become part of a team working for and reporting to the Head of Clinical
Operations. You will have primary responsibility for the set-up and management of several clinical studies
within the clinical operations department ensuring that the clinical studies are run to budget, timelines,
company SOPs, ICH/GCP standards and all other applicable regulations.
You will be expected to take responsibility for overseeing clinical trial administrators and other project team
members: delegating and managing their work and providing feedback to them and the Head of Clinical
Operations.
Reporting into Head of Clinical Operations
Small Pharma
Fully remote
UK
Permanent
Excellent benefits and career progression
Key responsibilities:
Skills and attributes
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
