Site Manager, On-Site

About the role

This individual will play a key role in assisting in the conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary skills include logical thinking, ability to prioritize, “can-do” attitude, the ability to adapt quickly to changing business conditions, strong interpersonal and team building skills. The employee, working closely with study team members, will achieve study objectives and corporate goals.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

Responsibilities

• Oversees the conduct of their assigned site; responsible for the training of staff/providers, process development, point of contact for the Directors of Operations and cross-functional teams
• Works closely with Business Development and Feasibility on study placement
• Accountable for enrollment success at sites across all studies; works to understand revenue expectations
• Develops and implements patient recruitment strategies; actively recruits to ensure enrollment targets are achieved
• Maintains significant depth of knowledge and experience in coordinating across multiple therapeutic areas
• Ability to coordinate as primary CRC on at least 6 studies of medium to high complexity, as well as back-up CRC on other studies when needed
• Conducts 1:1 meetings and annual reviews with site staff
• Assists in the development of the annual site roadmap
• Completes all protocol related training
• Performs quality control checks on source documentation and regulatory
• Works closely with Quality Assurance Department to ensure quality at site; creates processes and CAPAs to improve trends
• Performs patient/research participant scheduling
• Collects patient/research participant history
• Collects and maintains source documentation
• Performs data entry and query resolution
• Supports the collection and review of required essential study documents and reports
• Orders supportive study supplies (e.g., contracts, IXRS, lab kits, nonclinical supply materials, imaging and laboratory handling manuals, etc.)
• Adheres to an IRB approved protocol
• Obtains informed consent of research subjects
• Supports the safety of research subjects, report adverse events
• Coordinates protocol related research procedures, study visits, and follow-up
• Facilitates site qualification, study initiation, and monitoring visits, and study close-out activities
• Ensures proper collection, processing, and shipping of laboratory specimens
• Attends training(s) on leadership, communication, and other topics to help in the management of teams, as required
• May be asked to perform special project responsibilities and travel to other CCT locations when needs arise
• Complies with IQVIA, CCT, Clinic, and Sponsor policies, standard operating procedures (SOPs) and guidelines
• Performs other duties as assigned

Qualifications

• Must have clinical skills experience with patients to obtain vitals and perform procedures such as blood draws, EKG, etc.
• Must demonstrate the ability to fulfill responsibilities of CRC Level II
• Extensive knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
• Superior knowledge and experience of site operations and the drug development process
• Trained in leadership, project management and process development

Skills

• Logical thinking
• Ability to prioritize
• “Can‑do” attitude
• Ability to adapt quickly to changing business conditions
• Strong interpersonal and team building skills
• Leadership, project management, and process development training

Benefits

In addition to the base pay, incentive plans, bonuses, and/or other forms of compensation may be offered, along with a range of health and welfare and/or other benefits.

Pay

The potential base pay range for this role, when annualized, is $64,600.00 - $161,500.00. The actual base pay offered may vary based on a number of factors including job‑related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part‑time).

Schedule

Position may be offered on a full‑time or part‑time basis.