Hobson Prior are looking for a Clinical Project Manager to join a drug research and development company on a contract basis.
Our client concentrates on delivering pioneering treatments for illnesses that are mistreated.
Job Responsibilities :
Provide medical support internally for all Clinical Development Science - responsible project activities through a comprehensive understanding of the science, medicine, product environment and competitive landscape relating to the disease area.
Provide medical support externally based on thorough scientific review of relevant product data and consultation with internal and external experts.
Represent as the physician contact for sites and investigators during study start-up and study execution, act as a liaison between the company and clinical investigators, CRO’s, and CRA’s.
Present trial and compound related information at Investigator Meetings and internal training sessions.
Partake in medical review, interpretation, and reporting of the results of the research, including submission to health authorities.
Uphold knowledge of therapeutic areas and indications, as well as maintaining of relevant regulations and guidelines to ensure safe and ethical conduct of trials.
Support the assessment of new in-licensing opportunities and business development activities / due diligence evaluations.
Undertake product and therapeutic area reviews and provide evidence-based input to the study-related, strategic and regulatory documents.
Deliver the medical aspects of the Clinical Project Development Plan related to the indication and executing its implementation.
Contribute to the core medical / scientific information required in all clinical documents and assure production of high-quality documents.
Deliver medical input on behalf of CDS to the monitoring and analysis of the safety profile of the product together with Global Drug Safety.
Accountable for ensuring projects are adequately supported medically and prioritized.
Contribute to clinical / scientific content for submissions to regulatory agencies and IRBs / ethics boards, and answer to medical / scientific questions from Health Authorities.
Key Skills :
Good organizational skills and can effectively work as part of a team and self-sufficiently.
Motivated and energetic individual with high personal and ethical standards.
Flexible mindset and able to deliver on timelines and strict deadlines.
Excellent verbal and written communication skills.
Detail-oriented with a hands-on approach.
MD with at least 5 years of clinical / research experience.
Knowledge of drug development and clinical trial process.
Strong knowledge of regulatory requirements / International Council of Harmonisation (ICH) guidelines.
Experience with infectious or rare diseases is ideal.
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.
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Hobson Prior is acting as an Employment Agency in relation to this vacancy.