- 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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Junior Senior Clinical Trial Manager - City of London, Greater London, United Kingdom - Proclinical Staffing
Description
Clinical 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 ClinicalIf you want to know about the requirements for this role, read on for all the relevant .
You will have primary responsibility for the set-up and management of several clinical studieswithin 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 teammembers: delegating and managing their work and providing feedback to them and the Head of ClinicalOperations.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Remote working/work at home options are available for this role.