Clinical Project Manager
- Employer
- Hobson Prior
- Location
- Hertfordshire (GB)
- Salary
- Competitive Salary
- Start date
- 21 Mar 2019
- Closing date
- 20 Apr 2019
View more
- Discipline
- Clinical Research, Clinical Operations
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Management
Job Details
Hobson Prior are currently seeking a Clinical Project Manager for a biotechnology company based in Hertfordshire, on a permanent basis. Our client is currently working within early phase and ideally would look for individuals with previous exposure to early phase studies. In this role you will work with the Director of Clinical Operations and team to guide the execution of the deliverables for the clinical studies whether interventional or observational.
Job Responsibilities:
- Monitoring of study deliverables and support vendor relationships.
- Carry out protocol-related site management activities.
- Involvement in study planning and set-up activities including vendor management, project management, and coordination of study and implementation plans.
- Contribute to the design, content, and preparation of clinical protocols, amendments, consent forms, study guides, monitoring plans, CRFs, and subject information sheets as well as quality system maintenance for clinical programs.
- Assist in the identification of clinical trial investigators as required.
- Coordinate and take direct responsibility for activities associated with site start-up and management including review site-modified informed consent templates. May be required to be involved in the tracking of the budget and contract process.
- Monitor/Co-Monitor study sites.
- Contribute to or coordinate preparation and conduct of monitors workshops and investigator meetings.
- Provide input for screening and enrolment progress.
- Coordinate study-level investigational product arrangements and accountability and reconciliation
- Take part in and support study teams and other cross-functional teams as necessary.
- Deliver clinical site/CRO, vendor support by answering protocol-specific questions.
- Resolve patient eligibility questions and protocol deviations in cooperation with the Director of Clinical Operations, the Head of Clinical Research and the CRO.
- Co-operate with the CRO, the central lab and the Analytical team to coordinate shipment and analysis of clinical biological samples.
- Guide and monitor CRO and third-party vendor activities, including relationships and training, and the development of vendor specifications and scopes of work.
- Use relevant reports and identify progress of CRF data collection and query resolution.
- Monitor progress of studies, identify study-related trends/issues and work with the clinical Director of Clinical Operations and CRO to implement corrective actions when necessary.
- Assist in preparation and quality control of Clinical trial applications, clinical study reports, and regulatory submissions.
Key Skills:
- Ability to write and present clearly using scientific and clinical terminology.
- Capable of dealing with time demands, incomplete information and unexpected events.
- Good organisational and planning skills.
- Capable of working effectively in a team/matrix environment.
- Demonstrate initiative and creative thinking for problem solving.
Requirements:
- Life Sciences Degree - MSc or PhD.
- Previous biopharmaceutical clinical operations experience.
- Broad experience in life sciences or medically related field, including general knowledge of biopharmaceutical clinical research.
- Understanding of drug development process.
- Knowledge in clinical trial technologies (EDC, IVRS, WVRS, Vendor dashboards).
- Experience in interactions with vendors, such as CROs and contract labs.
- Involvement with administration of site budgets and grants with supervision.
- Experience with development of prospective site-selection criteria.
- Previous experience of reviewing adequacy of site-proposed ICs for compliance with relevant regulations.
- In-depth knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements.
Apply now:
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
Company
Providing recruitment solutions across the life sciences industry
Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.
Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.
Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.
We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.
Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.
Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.
Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.
Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.
Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.
Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.
- Website
- http://www.hobsonprior.com/
- Telephone
- 01892 612 612
- Location
-
Wellington Gate
7-9 Church Rd
Tunbridge Wells
TN1 1HT
United Kingdom
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