Clinical Monitoring Lead

Clinical Monitoring Lead – Contract – Cambridge, MA.
The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

An American Company is seeking a Clinical Monitoring Lead in Cambridge, MA.

Role Description

• Take responsibility for coordinating the clinical monitoring activities, overseeing the CRO clinical /site management activities and co-monitoring the assigned international Ph2/3 clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs to the most rigorous standards of quality, timely delivery and within budget, in order to assist in the delivery of Clinical Development objectives and achieve clinical excellence.
• Coordinate the achievement of assigned clinical study deliverables within a matrix organization under the leadership of the Clinical Project Managers (CPM).
• Be a representative at site and build relationship with our investigators.
Main responsibilities and tasks
• Ensure efficient and thorough study start-up by overseeing the Clinical team of the CROs and working closely with other relevant team members involved in the study set up (DM, Reg, CMC etc.…): ensure feasibility report are exhaustive, Review site feasibility reports as per oversight plan , support the CPM in site selection, verify timely collection of essential study documents, such as regulatory and ethics committee documents for submission, and by controlling that all set up activities are performed prior to each site initiation, as per the oversight plan.
• Support and ensure that all specific CRO EDC system tasks under the clinical responsibility are completed and achieved according to the defined timelines without jeopardizing the start of a trial.
• Support the Clinical CRO in the training of the CRAs on all study specific operational activities and participate in the organization and preparation of the monitor and investigator meetings in collaboration with the other study team members (Corporate and/or affiliates, CROs as appropriate)
• Assist the CPM/ study team in the evaluation of detailed timelines and establishment of clinical studies milestones for assigned projects, ensuring that they are performed to the most rigorous standards of quality and timely delivery.
• Prepare and/or assist in the production of all documents necessary to oversee the clinical activity implementation, monitoring and reporting in a professional, high quality and timely manner (such as monitoring oversight plan and clinical monitoring metrics…).
• Customize site Key Risk/Performance Indicator template and follow these KRIs/KPIs at frequency agreed in the oversight plan
• Validate the final clinical study documents (such as study manual, monitoring plan …) prepared by the Clinical CRO.
• Review all/a sample of site visit reports as per the Oversight Monitoring Plan, ensuring timely and appropriate follow up of issues raised by monitors (Corporate & affiliates and/or CROs as appropriate).
• If applicable, provide support and guidance to Internal CRAs (Corporate & Affiliates with provision of some supervision in specific cases).
• Coordinate and manage the CRO relationship, assisting CRO CRAs/CTLs when and where necessary.
• Collaboration with the CPM in the RFP process and participation to BID defense meeting
• If applicable to set up regular meeting with MSL (Medical Science Liaison) at LMA (Local Medical Affairs) who can support Clinical Operations at various steps (site qualification, site recruitment)

Skills & Requirements

• Relevant experience of pharmaceutical drug development:
• Experience of minimum 1 year (ideally 2 years) of Lead CRA e.g. coordination of clinical activities/site management activities for the set up and running of international registrational studies (multiple sites/countries).
• Experience as a Field CRA monitor for at least 3 years (CROs or Pharma Industry)
• Excellent Knowledge of Good Clinical Practice (GCP), ICH regulations.
• Experience in preparing clinical study documentation for study set up, maintenance and closing
• Experience in managing and developing relationships with Contract Research Organizations (CROs).
• Global studies (multiple countries)

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the Information Technology industry and market trends . Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.

• Medical
• Dental
• Vision
• 401K
• Life Insurance ($20,000 benefit)

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Hays is an Equal Opportunity Employer.

Drug testing may be required; please contact a recruiter for more information.

Summary

Job Type
Contract
Industry
Pharmaceuticals
Location
Cambridge
Specialism
Pharma
Pay
Competitive Salary
Ref:
1129322