Company: Barrington James Clinical
Closing Date: 12 Feb 17
Salary (£): 60,000 - 80,000
I am currently partnering an international bio-pharmaceutical company on a retained search basis that focuses on the discovery and development of novel medicines to treat the fatal muscle diseases and rare diseases. My clients long term plan is to become a fully integrated bio-pharmaceutical company focused on the discovery, development and commercialization of novel medicines for indications for which there are no existing or only inadequate therapies.
I am currently partnering an international biopharmaceutical company on a retained search basis that focusses on the discovery and development of novel medicines to treat the fatal muscle diseases and rare diseases. My clients long term plan is to become a fully integrated biopharmaceutical company focused on the discovery, development and commercialization of novel medicines for indications for which there are no existing or only inadequate therapies.
Basic: £55,000 - £75,000
+ Shares/Bonus/Pension/Dental/Health Care
Responsible for all aspects of Clinical Trials Management for the assigned project/s from study concept to close-out. Co-ordinates and leads all functional groups, under direction from Head of Clinical and ClinOps to develop clinical protocols and operations on clinical study/ies. Responsible for all performance metrics and quality of deliverables in the clinical trial.
Main tasks and responsibilities:
Interact with internal and external groups to facilitate clinical trials and achieve designated timelines. Develop proactive strategy/ies and corrective action(s) plan to address study issues in collaboration with internal team
Responsible for leading process for writing clinical protocols, working closely with Head of Clinical, medical writer and functional groups within the organization.
Responsible for the management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), Investigators Brochures, consent documents, letters of agreement, confidentiality agreements Organize Ethics Committee submissions with follow through to ensure successful outcome.
Responsible for reviewing and managing study related plans, processes including Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, CTA templates, safety monitoring
Leading all efforts for Request for Proposals CRO/Vendor selection
Responsible for managing CROs/ all Vendors involved in the clinical study, to ensure study delivers on time and within budget. Has experience in set-up and management of central labs, IVRS, Pharmacovigilance, IMP logistics, drug labelling, central ECG, specialized services vendors.
Responsible for managing all aspects of study start-up, conduct, data reviews/cleaning and close out activities. Oversee comprehensive close-out processes, ensuring final site issues are addressed appropriately.
Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPs.
Reviews pre-study, study initiation, interim monitoring visit and at study closeout visit report. Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates. Directs investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
Responsible for developing and managing study related budgets.
Responsible for oversight on the maintenance of the TMF and completeness at the end of the study. Perform periodic QC of the TMF
Responsible for oversight of the functional activities of Clinical Trial Associates allocated to the project
· At minimum, bachelor degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.
· A minimum of 5 years’ of experience managing Ph II-III International clinical trials in Pharma/Biotech organization.
· A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process.
· Budget forecasting and management
Competencies & Skills:
· Demonstrated ability to lead teams and work in a fast-paced team environment.
· Experience in working in a small organization
· Excellent interpersonal and decision making skills. Demonstrates innovation, possesses drive, energy and enthusiasm to deliver the program objectives.
· Demonstrated ability to comprehend complex scientific concepts and data.
· Proficient in reviewing and assessing clinical data.
· Possesses excellent planning, time management & coordination skills.
· Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs.
· Excellent written and oral communication skills.
For More information, please do not hesitate to reach out to me directly!
01293 77 66 44
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