Global Clinical Trial Manager *** UK*** Homebased / Permanent

Employer
DOCS Global
Location
United Kingdom, UK
Salary
Competitive
Closing date
15 Oct 2020

View more

Discipline
Clinical Research, Clinical Trials Manager / Administrator
Hours
Full Time
Contract Type
Permanent
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• Ensure regional/global clinical operations deliverables progress according to agreed upon
timelines and milestones as leader of the Study Management Team. This includes country & site feasibility and site selection, trial set-up, study execution and trial closure and vendor set up activities as assigned by the Global Trial Leader.

• Set-up country budgets and monitor actuals vs forecast for Out of Pocket Expenses, and review assigned vendor invoices/spend.

• Establish enrolment commitments and ensure actual enrolment meets projected commitment across the regions at the clinical trial level.

• Create and update study-specific documents such as Monitoring Guidelines, Informed Consent Form, IMP related documentation, Blinding Plan, country and site feasibility related documents.
• Provide input into cross functional documents such as Safety related documents, Protocol Deviations and Issue Escalation processes, External Service Provider Oversight Plan, Filing and Archiving Plan.

• Create appropriate trial-specific training materials and requirements, making them available to the site study staff and delivering training as needed. Responsible for the set-up and coordination of Investigator Meetings, if applicable, in close collaboration staff as well as Global Trial Leader.

• Act as the primary contact person for the local teams within the team.

• Establish and maintain excellent working relationships with internal stakeholders, including Local Trial Managers.
• Demonstrates deep knowledge of protocol and procedures and adequate therapeutic area knowledge.

• Ensure compliance with global health authority regulations and guidelines and internal operating procedures and processes. Participate in preparation for, and conduct of, Health
• Authority inspections and internal QA audits. Ensure that the Study Management Team operates in a constant state of inspection-readiness. Work with Quality Management (QM) liaisons to ensure quality oversight of assigned trial utilizing the available tools.

• Provides updates to all Study management Team as well as Trial Team members on the deliverable status. Ensure required reports are generated and available for real time tracking of trial status. Manage timely and accurate documentation, communication of study progress and issue escalation

Qualification and experience required:

• Strong clinical trial management experience in the pharmaceutical industry or CRO, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate's eligibility.

• Requires clinical research operational knowledge, strong project planning/management and effective communication skills, Should be flexible and have experience and ability in managing global or regional teams in a virtual environment. Proven track record in successfully managing trials from start- up to database lock. Experience with supervision of CROs/vendors is preferred.

• Specific therapeutic area experience may be required depending on the position.

• Strong decision-making and communication/collaboration skills are essential to this position, as are analytic skills and effectiveness in seeking solutions to issues.

• Effective leadership skills and proven ability to foster team productivity and cohesiveness. Computer literacy is also required.

• Willing to travel up to 20% of time.

Please note that this position is based in UK, you will need to have permanent right to work in the UK already as we do not provide sponsorship, although this is a home-based role, you will need to be located in UK in order to attend the Head office in Buckinghamshire for any team meetings.

#docs #pmjob

DOCS provides global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry. 

 

Our Values

At DOCS, we are driven by our core values that guide our culture and support our goal to become a Trusted Partner. Our five core values are:

OUR PEOPLE: We attract, source, develop and retain the best talent to enables us provide world-class people and solutions for our clients.

EXCELLENCE: We never stop looking for new, better ways of working.

ACCOUNTABILITY: We take responsibility for our actions, owning our client’s problems and proactively looking for solutions.

INTEGRITY: Becoming a trusted partner means being honest, respectful and ethically sound, at all times.

OPENNESS: We encourage and facilitate an open and inclusive environment for a diverse global network of employees and stakeholders.

Contact Us
  • 2 Globeside
  • Globeside Business park
  • SL7 1HZ
  • United Kingdom
  • +44 (0) 2380 688500
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