Clinical Trial Manager - Remote
- Employer
- i-Pharm Consulting
- Location
- USA
- Salary
- Negotiable
- Start date
- 22 Jun 2022
- Closing date
- 6 Jul 2022
View more
- Discipline
- Clinical Research, Study Start Up
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
What you will be Doing
Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes, including:
- Coordinate site management activities:
- Site identification, recruitment, and selection.
- Regulatory document collection and review.
- Overall scheduling and management of all site visits.
- Develop site/monitoring tools and training materials.
- Review and identify trends in enrolment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions.
- Coordinate and oversee daily operations of clinical monitoring team:
- Set and enforce project time-lines with the assigned study team.
- Coordinate remote review of clinical data within EDC system.
- Oversee monitoring visit schedule to ensure compliance with frequency set forth in contract.
- Review and approve trip reports and follow-up letters within required time-frame.
- Manage quality and regulatory compliance among clinical monitoring team and investigation sites.
- Manage project milestones and proactively address deficiencies
Required Experience
- Thorough knowledge of clinical research process.
- Strong communication skills (verbal and written) to express complex ideas.
- Excellent organisational and interpersonal skills.
- Ability to manage multiple priorities within various clinical trials.
- Ability to reason independently and recommend specific solutions in clinical settings.
- Understanding of basic data processing functions, including electronic data capture.
- Working knowledge of current ICH GCP guidelines and applicable regulations.
- Ability to work independently, prioritize and work with a matrix team environment is essential.
- Prior experience in electronic data capture (EDC) preferred.
- Able to mentor CRAs and more junior Clinical Trial Managers.
- BS/BA (or equivalent) in one of the life sciences and a minimum of 4 years direct experience in clinical studies
- Minimum of 4 years as a Clinical Monitor/CRA, as well as experience in data handling or analysis
- Minimum of 2 years as a successful Clinical Trial Manager.
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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