The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Sponsorship not available.

Our client is seeking a Clinical Monitoring Lead in Cambridge, MA.

Role Description

Ensure clinical activities coordination & oversight:
• 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.
• 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).
• 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)
Ensure the monitoring oversight of different activities entrusted:
• Co-monitor clinical studies according to the oversight plan, ensuring adequate contact with investigator sites, identifying, and solving issues in study progress, verifying data in-house or by conducting co-monitoring visits, in collaboration with other study team members, and following up as required with CROs/CRAs/investigator.
• Ensure the agreed timelines for data collection (CRF/eCRF) and data clarifications/queries are met, sending information to data-management and monitoring CROs as appropriate.
• Ensure that study samples/assessments flow as required per protocol is well coordinated between the various stakeholders (CROs/Vendors) from site to the central facility/specialized lab.
• As appropriate, participate in the preparation of study documents and perform site visits prior to audits

Skills & Requirements

Education / Certifications:
• Minimum: CRA (Clinical Research Associate) graduate
• Life science or medical graduate or other relevant qualifications.
• 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.
Languages: English: Strong intermediate level
Key Technical Competencies Required

• Ability to work in a strong regulated environment within a quality management system (QMS)
• Advanced knowledge of software application (ex: Word, Excel, PowerPoint, Adobe Reader …)
• Ability to organize and prioritize.
• Able to produce work in teams and within a multi-disciplinary environment.
• Basic Financial Knowledge - must be able to work with financial tracking tools.
• Knowledge of Pharmaceutical Industry R&D
• Excellent knowledge of Good Clinical Practices, ICH regulations and any others as appropriate and other clinical study regulations - Continuous drive to improve one’s knowledge and performances (in terms of quality, timeliness, and costs)
• Strong organizational, coordinating & coaching plus interpersonal skills.
• Excellent verbal and written communication skills
• Show professional awareness and integrity.
• Demonstrate a pragmatic/hands-on approach.
• Ability to work within a team and multidisciplinary & matrix environment, support others.

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the 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.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

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

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