Clinical Study Manager

A historic pharmaceutical company is seeking to recruit a Clinical Study Manager to their office in the UK. The organisation creates informative and engaging online communities that share information in meaningful ways. This vacancy offers an exciting opportunity to work with a leading and innovative pharmaceutical organisation that develops high quality medicines that meet real needs.

Job Responsibilities:

• Assuming site level accountability from Site Selection through Site Closeout.
• Acting as the primary point of contact for institutions to identify and proactively resolve business process barriers.
• Partnering with other functional partners and vendors interacting with the sites and serving as the single point of accountability for the site (site selection, site activation, enrolment, data delivery, issue management, and closeout).
• Influencing the development and implementation of site initiation/enrolment risk plans for clinical
  trials to ensure delivery on enrolment commitments.
• Owning the issues management process at the site level, collaborating with company partners, Quality, and other team members through both formal and informal interactions to resolve/escalate site specific issues when necessary.
• Overseeing the delivery of data and clinical trial milestones at the site level.
• Leveraging strategic knowledge of institution's decision-making process along with historical performance with other company clinical trials to deliver mutually acceptable business solutions.
• Identifying, screening, evaluating, and developing investigators for clinical trial participation.
• Influencing the design of clinical study protocols including input to study manager on protocol and enrolment feasibility for studies to enable the successful enrolment and implementation of the
  clinical trial.
• Maintaining technical expertise within a therapeutic area to engage in scientific discuss ions with the
  investigator and institution personnel.
• Developing and maintaining relationships with therapeutic clinical trial sites.
• Negotiating budgets and contracts with institutions and investigators with an emphasis on usage of standard agreements and Fair Market Value (FMV).
• Serving as the primary sponsor point of contact for site personnel relative to clinical trial related issues.
• Serving as an effective communication "bridge" between our sites, third party vendors, and the company.
• Overseeing site level accountability for inspection readiness throughout the trial and in support of regulatory inspections.
• Influencing and challenging internal and external environmental factors that impact clinical research strategy.

Skills and Requirements:

• Scientific background with a medico-scientific university degree.
• Previous experience in multiple aspects of pharmacovigilance activities.
• Project management experience preferred or experience in managing complex projects.
• Working knowledge of global safety regulatory requirements.
• Proven good communication skills and evidence of ability to work in cross functional teams.
• Demonstrates excellent scientific/clinical or analytical knowledge base, with ability to assess data and understand the safety/medical or process implications.
• Competent in abilities in area of expertise and the wider areas of PVE
• A good knowledge and understanding of applicable regulatory requirements.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.

• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Matthew Pike at +44 207 440 0639 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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