Clinical Study Manager

Sterling-Hoffman Executive Search Located in: Quebec
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JOB DESCRIPTION

A leading company in the biopharmaceutical industry is currently seeking a Clinical Study Manager to join their team. For the right candidate, this is a fantastic opportunity with great growth prospects. Details:

1) Follow the progress of clinical studies to ensure protocol, GCP and SOPs compliance
2) Report all major protocol deviations and/or non-compliance issues to the immediate supervisor in a timely manner
3) Participate in CRA identification and selection
4) Train and evaluate CRAs
5) Supervise CRA activities required to monitor the clinical protocols
6) Manage and decide monitoring priorities with the CRA
7) Ensure that monitoring activities are done in agreement with the approved monitoring plans
8) Review and approve CRAs' monitoring reports when needed
9) Work closely with CRAs to ensure appropriate action to rectify observed problems or non-compliance issues
10) Ensure efficient communication between the sites and the company when the CRA is not available
11) Collaborate with other groups within the company such as Data Management, Medical Monitoring, Medical Writing and Finances to support milestone achievement and to manage study issues and obstacles
12) Follow closely the recruitment at each site in order to meet the schedule attributed to each protocol
13) Conduct monitoring visits/quality control visits when needed
14) Participate in the development of relevant Standard operating Procedures
15) Prepare and review monitoring plans, regulatory documents, source documents templates, telephone scripts and other related protocol documents
16) Participate in the writing of informed consents and CRF creation
17) Supervise the maintenance of the Sponsor Master Trial Files as per SOPs
18) Maintain up to date knowledge of SOPs and GCPs and applicable regulations

CRITICAL REQUIREMENTS

  • 1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
    2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
    3) Recent experience in the biopharmaceuticals industry is strongly preferred
    4) Preference will be given to people having recent experience in clinical management

    If you're a confident communicator with an ability to manage multiple tasks at one time and thrive in a busy atmosphere, this could be a great opportunity for you.

COMPANY INFORMATION

Sterling-Hoffman is a retained executive search firm that specializes in representing life sciences and technology companies in matters of high impact talent acquisition. Our clients include market leaders and venture capital-backed startups in industries such as: medical device, biotechnology, pharmaceuticals, enterprise software, clinical research, and laboratory services. You may view more of our jobs here: http://www.sterlinglifesciences.com Your privacy is important to us: we will never share your resume without your permission. Please note that only qualified applicants will receive a response. We encourage you to apply for as many jobs as you believe you are a fit for, but strongly suggest that you include your salary information as job seekers who provide salary information are likely to be reviewed sooner. ===================== TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Biotechnology Recruiter, Pharmaceutical Recruiter, Medical Device Recruiter, Biotechnology Career, Clinical Research Job, Regulatory Affairs Job, R&D / Scientist Job, Product Manager Job, Medical Device Sales Job, Biotechnology Sales Job, Quality Assurance Job, Engineering Job, Laboratory Jobs, Microbiology Jobs, CEO Jobs, Marketing Jobs, Manufacturing Jobs, Oncology Jobs, Cardiology Jobs, Hematology Jobs, Medical Jobs

JOB INFORMATION

Seniority Level:
Management / Supervisory
Function:
  Clinical Research / Affairs,  R&D / Science,  Medical Affairs
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation:
A superb base salary and bonus structure are available; compensation is commensurate with experience and will be discussed with qualified candidates only.