Clinical Trial Manager - UK Based
- Employer
- i-Pharm Consulting
- Location
- England / London, England
- Salary
- GBP52000.00 - GBP600000.00 per annum
- Start date
- 28 Nov 2022
- Closing date
- 12 Dec 2022
View more
- Discipline
- Clinical Research, Clinical Study Manager
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Senior Management
Job Details
The Clinical Trial Manager (CTM) will be accountable for the operational management of the regional/local component of clinical trials. As CTM, you will maintain oversight to ensure the achievement of trial recruitment commitment, timelines, budget and internal/external quality standards.
Accountabilities
Trial Preparation, Conduct and Closeout:
Selected sites conduct and deliver the trial according to the clinical trial protocol, within trial timelines, and in compliance with ICH-GCP and all other relevant external regulations
Lead and support local trial team and investigative sites in timely preparation of required trial documents, contracts and necessary approvals
All Regulatory requirements are satisfied prior to trial/site initiation
Where necessary, set up and manage external suppliers that meet requirements of local/regional trial operations
Set up, manage and review UK & Ireland trial budget to ensure appropriate level of financial oversight
Timely budget updates based on trial changes
Ensure appropriate trial-specific training of UK & Ireland internal and external partners in line with Trial Training Plan
In collaboration with Site Monitoring Lead and CRAs, ensure provision of appropriate trial oversight for the trials by monitoring compliance of trial sites and team to GCP, local regulations, SOPs and adherence to trial protocol
Ensure adequate trial supply distribution to sites
Trial contact for CRAs, investigators and site staff
In collaboration with Trial Records Specialist and with supports from CRAs as appropriate, ensures collection of required documents, with timely, complete and compliant archiving of all relevant documents for the eTMF and CTR Appendices
Management and Relationship Responsibilities:
Develop and maintain company relationships with external experts and investigational sites by coordinating and ensuring cross-functional collaboration amongst Clinical Operations and Medical Affairs on Regional/ local level and supporting CRAs in site contacts
Collaborates with other functions to support Trial Management topics and support integration across Medicine
Participate in working groups related to Trial
Represent Trial on local and regional level, providing updates on trial within UK & Ireland
Provide mentoring to other members of the department as assigned
Regulatory and Organizational Requirements:
Ensures all tasks are carried out in accordance with respective applicable SOPs, Business Practices and regulatory requirements
Ensures that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with sponsor Values
Company
i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.
We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.
Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world.
With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.
For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them.
As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.
We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.
- Website
- http://www.i-pharmconsulting.com/
- Telephone
- +44 (0) 20 3189 2299
- Location
-
52 Bedford Row
London
England
WC1R 4LR
United Kingdom
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