[Hiring] Manager, Clinical Operations Site Management @Worldwide Clinical Trials

Role Description

The Manager, Clinical Operations Site Management is responsible for providing management of assigned Clinical Research Associates (CRAs), including ensuring work effectiveness, optimal utilization, and performance.

What you will do

• Responsible for interviewing and selecting CRA/In‑House Clinical Research Associate (IHCRA) candidates
• Ensure consistent onboarding of permanent and contract CRAs/IHCRAs
• Ensure CRAs are properly and timely trained to perform all types of visits as well as other billable monitoring activities
• Provide on‑site mentoring for CRAs through observation or site assessment visits
• Establish regular communication and 1:1 calls with CRAs/IHCRAs to review and discuss quality metrics (such as site visit report compliance, source data verification metrics, trial master file readiness, expense report submissions, and project status)
• Manage the quality of assigned CRAs/IHCRAs
• Act as a point of escalation for CRA/IHCRA performance issues on projects
• Review timecards, including reviewing and approving hours billed by contractors
• Review the accuracy of Sciforma assignments and workload
• Conduct performance appraisals, reward and discipline employees, address employee relations issues, and resolve problems
• Write and conduct corrective and preventive actions (CAPAs) when necessary; support Directors of Clinical Operations
• Approve CRA/IHCRA paid time off (PTO) requests
• Review and approve CRA/IHCRA non‑billable expenses

The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Qualifications

• Ability to understand multiple study protocols
• Superior oral and written communication skills
• Strong planning and organizational skills
• Good interpersonal skills
• Experienced problem‑solving and decision‑making skills
• Strong attention to detail
• Understanding of clinical research principles and processes, including data collection and editing skills
• Ability to navigate Electronic Data Capture (EDC) software such as InForm and Medidata
• Strong knowledge of U.S. Food and Drug Administration (FDA) regulations, International Council for Harmonisation (ICH) guidelines, and the Health Insurance Portability and Accountability Act (HIPAA)
• Understanding of standard operating procedures
• Knowledge of therapeutic areas
• Knowledge of Microsoft Word, Excel, and Outlook

Requirements

• Four‑year college curriculum with a major concentration in biological, physical, health, pharmacy, or other related sciences and six years of clinical research experience as a clinical research associate, OR
• Two‑year college curriculum (unless holding a nursing degree; then see requirement above) or equivalent education/training and seven years of clinical research experience as a clinical research associate, OR
• Eight years of clinical research experience as a clinical research associate or in another position directly related to clinical research with a pharmaceutical or biotechnology company
• Two years of management experience
• Travel required
• Passport required

Benefits

• Salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates):
• United States of America - $97,000.00 - $222,000.00
• Compensation will fall within the provided range, and it is not a guarantee of exact salary.
• The final salary will be determined based on relevant experience, performance, education, and internal equity.
• In addition to base salary, we offer a competitive benefits package depending on location.
• We ensure pay equity and transparency and comply with all applicable labor laws.