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Clinical Monitoring Lead - 132

Remote, MA 02142

Posted: 11/08/2021 Industry: Scientific and Life Sciences Job Number: 13548

Job Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.

Title: Clinical Monitoring Lead

Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type

  • Duration: contract to hire
  • Pay rate: $65-$138/hr based on experience
  • Job Location: 100% Remote -or- Hybrid based on location (Boston Metro)
  • Job#: bh13548

 

Clinical Monitoring Lead
 

In order to set expectations and to the extent permitted by applicable law, please note that if an applicant is hired for this position, the applicant will be required to prove that the applicant has been fully vaccinated against COVID-19 by the date of hire, subject to any qualified religious or medical exemptions. Please note that the employer reserves its rights to mandate additional vaccine requirements at any time.

 

Purpose of the position:

  • 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 company 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)

 

Experience:

  • 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/sites) experience
  • Previous experience in the Therapeutic area of studies (Neuroscience, Oncology or radiopharmaceutical compound, etc.. ) is a plus

 

Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.

 

When responding to this job posting you MUST include the Job# and Job Title in your subject line.

 

If you are active in a job search but this job is not for you, please reach out to jobpostings@csetalent.com. We would be glad to help you find the perfect job!

Meet Your Recruiter

Caroline Driscoll
Major Account Mgr, Sr. Technical Recruiter

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