Principle Clinical Trial Manager, CVRM (Home-Based) - IQVIA Biotech

IQVIA Biotech is seeking a Principle CTM to join our team. Previous global /program-level clinical trial management experience required; Strong Cardiovascular experience required - Experience with thromboembolism preferred.

BASIC FUNCTIONS:

Responsible for the successful planning, implementation and execution of contracted clinical monitoring activities.  Functionally responsible for all clinical monitoring team members throughout the duration of each clinical trial.  Assures clear client and internal team communication, process documentation, and compliance with Good Clinical Practices and procedures set forth by IQVIA Biotech and its clients.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

Responsible for all activities related to implementation and execution of clinical studies that include:

Client Duties/Responsibilities:

• Work 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.
• Serve as client advocate within IQVIA Biotech.
• Develop and implement Clinical Monitoring Plan.
• Participate in bid defense preparations. Lead the Clinical delivery strategy at bid defense presentations in partnership with Project Leader Business Development for large, complex, multi-region studies (may include mega studies). Understand the overall project strategy and translate the agreed upon clinical approach to a successful practical delivery model.  
• Serve in PM/CTM combo role.

Team Duties/Responsibilities:

Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes, including:

• Coordinate site management activities

• Site identification, recruitment, and selection. 
• Regulatory document collection and review.
• Overall scheduling and management of all site visits.
• Develop site/monitoring tools and training materials.
• Review and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions.

Coordinate and oversee daily operations of clinical monitoring team as assigned:

• Set and enforce project timelines with the assigned study team. 
• Coordinate remote review of clinical data within EDC system.Oversee monitoring visit schedule to ensure compliance with frequency set forth in contract.
• Review and approve trip reports and follow-up letters within required timeframe.
• Schedule and manage weekly CRA project team meetings.
• Ensure CRAs assigned to team receive therapeutic and project-specific training.
• Manage quality and regulatory compliance among clinical monitoring team and investigational sites.
• Where applicable, serve as global/program CTM coordinating and overseeing a project team of regional CTMs.
  • Assist the Project Manager/Director in recognizing systemic issues at a program/project level.
  • Identify solutions with the project teams, recommend actions to improve efficiencies and oversee the implementation of best practices within the respective clinical teams.
  • Support the Project Manager/Director with escalation to the client.

Manage project milestones and proactively address deficiencies:

• Attend and provide information at monthly projections meetings.
• Attend and provide information at weekly client teleconferences/team meetings.
• Assist Project Manager in identifying Out of Scope activities and assuring that such activities do not begin until the client provides authorization.

Manage CRA performance:

• Define and implement functional standards, goals, and expectations with clinical monitoring team.
• Serve as CRA mentor and perform accompanied field assessment visits as required.
• Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of each respective CRA.

Documentation Duties/Responsibilities:

• Assure that the appropriate IQVIA Biotech and/or sponsor SOPs are followed.
• Ensure all project documentation is appropriately filed per IQVIA Biotech SOPs.
• Assist PM in preparation of audit responses, as appropriate.
• Assist PM with preparation of information for inclusion in monthly report to client.

Budget/Contract Duties/Responsibilities:

• Assist PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions.
• Define the scope of work with the client and clinical monitoring team.
• Assist PM in identifying and generating changes in scope and notify client of potential changes in scope.
• Review and approve CRA travel expenses and time sheets.

Department Duties:

• Serve as department CTM mentor/buddy.
  • Assist Line Management with new CTM and CRA onboarding.
• Serve as therapeutic subject matter experts and provide therapeutic level training to clinical teams (including but not limited to CSA, CRA and CTM staff).
• Participate in and/or serve as a champion for department and company-wide initiatives.

KNOWLEDGE, SKILLS & ABILITIES:

• Thorough knowledge of clinical research process, including medical and therapeutic areas, phases and medical terminology.
• Prior experience as a Clinical Research Associate.
• Excellent communication skills (verbal and written) with ability to express complex ideas.
• Strong presentation skills.
• Strong negotiation skills with the ability to communicate difficult concepts clearly.
• Excellent organizational skills and proficient at multi-tasking with strong attention to detail.
• Strong interpersonal skills, with flexibility to adapt to changing situations.
• Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
• Prior experience leading, liaising and coordinating cross-functional project teams preferred, but not required.
• Ability to lead, motivate and coordinate local and virtual teams.
• Ability to manage multiple priorities within various clinical trials.
• Ability to reason independently and recommend specific solutions in clinical settings.
• Ability to delegate, effectively prioritizing own and workload of project team members.
• Understanding of basic data processing functions, including electronic data capture; ability to effectively use automated systems and computerized applications.
• Possesses cross cultural awareness and is able to adapt appropriately.
• Working knowledge of current ICH GCP guidelines and applicable regulations.
• Able to mentor CRAs and Clinical Trial Managers.
• Able to qualify for a major credit card.
• Valid driver’s license; ability to rent automobile.
• Willingness and ability to travel domestically and internationally, as required.

MINIMUM RECRUITMENT STANDARDS:

• BS/BA (or equivalent) in one of the life sciences with a minimum of 4 years direct experience in clinical studies or equivalent level of education and experience. 
• Minimum of 6 years as a Clinical Monitor/CRA or equivalent industry experience, as well as experience in data handling or analysis. 
• Minimum of 4 years as a successful Lead CRA or Clinical Trial Manager or equivalent industry experience.
• Ability to work independently, prioritize and work with a matrix team environment is essential. 
• Working knowledge of Word and Excel. 
• Prior experience in electronic data capture (EDC) preferred. 

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

• Ability to travel domestically and internationally
• Very limited physical effort required to perform normal job duties

CLASSIFICATION: 

This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

In compliance with the Colorado Equal Pay For Equal Work Act, salary range is displayed - Salary Pay Range: $97,790 - $127,000