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BASIC FUNCTIONS:

Responsible for the planning, tracking, and reporting of patient samples and blood/cellular products inherent to cellular therapy (CAR-T), and other logistically complex trials. Assists in training, site management, and aspects of cohort management directly related to cell therapy-based trials.  Responsible for the successful management, performance, and career development of Clinical Research Associates (CRAs) and Clinical Monitoring Assistants.  Staff may be office or regionally based.  Provides training and consultation related to clinical operating activities in the conduct of clinical trial projects.  Serves as a source of scientific and therapeutic expertise for IQVIA Biotech staff.  Contributes to, and participates in, the marketing of IQVIA Biotech services.  Assures compliance with Good Clinical Practices (GCPs), ICH, Standard Operating Procedures (SOPs), Working Practices (WPs), and policies and procedures set forth by IQVIA Biotech and its clients.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

Client Duties/Responsibilities:

• Work with Clinical Trial Manager (CTM) to ensure the client is regularly and clearly updated on the status of patient slot allocation, donor scheduling (if Allogeneic), apheresis scheduling, manufacturing timelines, shipment status and other elements of cellular therapy logistics. Communicate and document all interactions with client as required by SOP and Communications Management Plan.

• Develop and implement the study-specific Logistics Management Plan.

• Attend scheduled and ad hoc client meetings as necessary.

Team Duties/Responsibilities:

Responsible for assuring needs of clinical sites are met by being a point of contact for various logistical considerations, including:

• Coordinating patient and donor (if Allogeneic) scheduling timelines for apheresis, cell manufacturing, lymphodepletion, and infusion.

• Support the CTM in informing sites about cohort slot availability, screening status, and pre-screening scheduling considerations.

• Contact appropriate site staff proactively to coordinate and confirm shipment timelines for apheresis yield.

• Serve as liaison between study sites and logistics vendors, couriers, and the sponsor.

• Develop site sample-tracking tools and training materials.

• Complete training for, and utilize/implement, logistics-vendor tracking platforms/interfaces such as TrakCel, Vinetti, Cryoport, etc. (when applicable).

• Participate in Site Initiation Visits (SIVs) and/or SIV “Dry-Run” with CRA and applicable site staff, when necessary.

• Manage quality and regulatory compliance among investigational sites.

Manage project milestones and proactively address deficiencies:

• Attend and provide information at weekly client teleconferences/team meetings.

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.

Clinical Staff Line Management Duties/Responsibilities:

• Line management of a group of clinical staff (both office and regionally based) in the following areas:

  • Monitors project hours and overall workloads:

    • Anticipate resource issues and plan remedial action.

    • Work with Director, Clinical Monitoring, in the allocation of monitoring resources.

    • Work with Clinical Trial Managers (CTMs) to ensure correct monitoring resources per project.

    • Liaise with Project Managers to ensure project hours are met and excessive total hours are noted, and action taken as necessary. 

    • Make sure the Director, Clinical Monitoring, is aware of all project issues and results of discussions with Project Managers and CTMs.

    • Review and approve time sheets and expense reports as required.

• Appraises performance of direct reports:

  • Plan career development of staff. 

  • Assess training requirements for monitoring staff.

  • Organize appropriate training in liaison with the IQVIA Biotech e-process and Integration (Training) Department.  Monitor and record subsequent performance to assess the effects of training on efficiency.

  • Conduct monitoring assessment visits with staff at sites.

  • Hold regular one-on-one meetings with staff to discuss performance.

  • Write and conduct annual performance appraisals at year-end.

• Coaches, trains, and supports direct reports:

  • Provide staff with expert clinical research and therapeutic advice.

  • Organize and conduct clinical staff meetings at regular intervals.  Deal with issues raised at meetings.

  • Maintain an awareness of company policies to effectively represent the company perspective to clinical staff.

  • Identify training needs and ensure staff participation during in-house training activities as required.

  • Develop and administer an effective orientation/on-boarding process for new hires.

  • Maintain awareness of overall development in the field of clinical research and ensure that staff remains current on clinical monitoring developments.

Clinical Monitoring Department Duties/Responsibilities:

• Assist Director, Clinical Monitoring with review and revision of departmental SOPs, working practices, and policies.

• Interview and make hiring recommendations and/or decisions on new staff.

• Keep Director, Clinical Monitoring aware of needs for increases in staff and equipment.

• Keep Director, Clinical Monitoring apprised of staff training needs.

• Participate in and/or serve as a champion for department and company-wide initiatives.

New Business Development Duties/Responsibilities:

• Participate in the development of the clinical portion of client proposals including the budget process.

• Participate in marketing activities, client presentations, and proposal development.

• Participate in bid defense preparations.  Lead the Clinical delivery strategy at bid defense presentations in partnership with the Clinical Trial Manager (CTM) or representative. Understand the overall project strategy and translate the agreed upon clinical approach to a successful practical delivery model.  

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 or equivalent site-facing/site-based experience.

• Excellent communication skills (verbal and written) to express complex ideas.

• Strong understanding of cohort-based studies and slot allocation methods preferred.

• Strong presentation skills.

• Strong negotiation skills with the ability to communicate difficult concepts clearly.

• Positive attitude and ability to interact with all levels of staff.

• Prior experience leading, liaising and coordinating cross-functional project teams preferred.

• Ability to lead, motivate and coordinate local and virtual teams.

• Ability to balance needs of the organization with needs of staff.

• Ability to protect confidential/sensitive information.

• Ability to manage multiple priorities within the department and across staff.

• Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings.

• Ability to delegate, effectively prioritizing own and workload of project team members.

• Ability to mentor CRAs, when needed.

• Understanding of basic data processing functions, including electronic data capture.

• Possesses cross cultural awareness and is able to adapt appropriately.

• Working knowledge of current ICH/GCP guidelines and applicable regulations.

• Able to qualify for a major credit card.

• Valid driver’s license; ability to rent automobile.

MINIMUM RECRUITMENT STANDARDS:

• BS/BA/BSc Hons (or equivalent) in a life sciences program or RN/BSN (or equivalent) with a minimum of 8 years direct experience in clinical studies or equivalent level of education, training and experience. Understanding of the entire clinical research process mandatory. 

• Experience with cellular therapy and CAR-T trials required.

• Previous experience in personnel management within a clinical research environment preferred.

• At least 4 years as a Clinical Research Associate/Clinical Monitor, including at least 2 years as a successful Lead CRA/Clinical Trial Manager.

• Demonstrated ability to lead and motivate a group of clinical research personnel.

• Excellent organizational, communication (verbal and written), and interpersonal skills. 

• Ability to work independently, prioritize and function effectively within a matrix team environment. 

• Working knowledge of Word and Power Point, strong command of Excel. 

• Prior experience in electronic data capture (EDC) s preferred.

• Prior experience in a Contract Research Organization (CRO) is preferred.

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

• Ability to travel domestically and internationally up to 40%.

• Very limited physical effort required to perform normal job duties.

CLASSIFICATION:

US: 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.