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Senior Clinical Operations Manager-Cambridge-UK-Contract

Employer
NonStop Consulting
Location
Cambridgeshire
Salary
Negotiable
Closing date
Oct 17, 2019

View more

Sector
Science, Life Sciences, Neuroscience
Contract Type
Contract/Freelance
Hours
Part Time
Organization Type
Corporate
Jobseeker Type
Professional

Job Details

We are delighted to get in touch with experienced Clinical Operations Managers to introduce you to our successful client based right outside Cambridge, for a flexible 12-18 months assignment with high chances of career progression.

Practically, you will take operational responsibility for early development trials from planning to close-out in an outsourced model. In addition, you will establish key operational policies for the clinical development team, fit for purpose for the business. This key role will manage, plan, and oversee execution of clinical studies, including creating and managing study timelines, budgets, and study management plans in accordance with GCP and regulatory requirements.

Main responsibilities:

  • Oversee and manage all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines
  • Assist development and maintenance of key clinical operations SOPs to support an outsourced/oversight model of early clinical development at Mission Therapeutics
  • Collaborate effectively with other key trial functions (e.g. Translational Medicine, Medical, Stats/DM, Regulatory, QA) to deliver successful trial execution.
  • Partner with CMC/clinical supplies to provide drug supply assumptions and contribute to design and packaging of supplies for clinical trials
  • Lead the evaluation, selection and management of Contract Research Organisations (CROs) and other external vendors to ensure successful clinical trial implementation and execution. Provide operational input into MSAs/WOs.
  • Create, manage, and execute clinical operations programs, including study management, and budget and Gantt timeline creation
  • Develop and ensure execution of activities outlined in various study plans (e.g. study management and deviation management plans)
  • Assist development of and author components of key study documents such as clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and other clinical documents as necessary
  • Develop and execute TMF strategies for each trial
  • Develop and execute risk assessment strategies for each trial
  • Co-monitor or monitor studies if needed for the program
  • Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
  • Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed
  • Participate in preparation of regulatory filings (e.g. IND, pre-IND, orphan applications etc.) as needed

Are you up for the challenge? If you do, please share your CV to discuss further.

Company

Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries. 

Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery.  Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.

The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors. 

Company info
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