Clinical Trial Manager

RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.

Primary Responsibilities

• Responsible for all activities related to implementation and execution of clinical studies.
• Works with Project Manager (PM) to define program targets for clinical monitoring staff and assure work is documented within contracted project scope. Communicate and document all interactions with client as required by SOP.
• Serves as client advocate within RQM+.
• Develops and implements Clinical Monitoring Plan.
• Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes.
• Coordinates site feasibility activities such as site identification, recruitment, and selection.
• Coordinates Regulatory document collection and review.
• Schedules and manages all site visits.
• Develops site/monitoring tools and training materials.
• Reviews and identifies trends in enrollment and data entry at sites and proactively interfaces with clinical monitoring team and client to identify solutions.
• Coordinates and oversees daily operations of clinical monitoring team.
• Sets and enforces project timelines with the assigned study team.
• Coordinates remote review of clinical data within EDC system.
• Oversees monitoring visit schedule to ensure compliance with frequency set forth in contract.
• Reviews and approves trip reports and follow-up letters within the required timeframe.
• Schedules and manages CRA project team meetings.
• Ensures CRAs assigned to team receive therapeutic and project-specific training.
• Manages quality and regulatory compliance among clinical monitoring team and investigational sites.
• Manages project milestones and proactively addresses deficiencies.
• Attends and provides information at client teleconferences/team meetings.
• Assists Project Manager in identifying Out of Scope activities and assuring that such activities do not begin until the client provides authorization.
• Serves as CRA mentor and performs accompanied field assessment visits as required.
• Participates in the performance appraisal program by providing timely and accurate feedback regarding the performance of each respective CRA.
• Ensures that the appropriate RQM+ and/or sponsor SOPs are adhered to.
• Ensures all project documentation is appropriately filed per RQM+ SOPs.
• Assists PM in preparation of audit responses, as appropriate.
• Assists PM with preparation of information for inclusion in monthly report to client.
• Assists PM in review of project budgets, monitoring costs, potential overruns, and propose/implement cost effective solutions.
• If requested, reviews and approves CRA travel expenses and time sheets.

Requirements

• BS/BA (or equivalent) in one of the life sciences and a minimum of 5 years direct experience in clinical studies
• Minimum of 4 years as a Clinical Monitor/CRA, as well as experience in data handling or analysis
• Minimum of 1 year as a successful Lead CRA or Clinical Trial Manager.
• Equivalent combination of education, training, and experience
• Thorough knowledge of clinical research process.
• Strong communication skills (verbal and written) to express complex ideas.
• Excellent organizational and interpersonal skills.
• Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
• Ability to manage multiple priorities within various clinical trials.
• Ability to reason independently and recommend specific solutions in clinical settings.
• Understanding of basic data processing functions, including electronic data capture.
• Working knowledge of current ICH GCP guidelines and applicable regulations
• Ability to work independently, prioritize and work with a matrix team environment.
• Working knowledge of Word, Excel, and PowerPoint.
• Prior experience in electronic data capture (EDC) preferred.
• Ability to mentor CRAs.
• Willingness and ability to travel domestically and internationally, as required.

Behaviours

• Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning

Supervisory Responsibilities

• This position does not have supervisory responsibilities.

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