Manager, Clinical Operations Site Management

Worldwide Clinical Trials; Milwaukee (WI); On-site; USD 97,000 - 222,000; Full time

Benefits offered by this job

Competitive benefits package

Pay equity and transparency

Career development opportunities

Job summary

Worldwide Clinical Trials in the United States is seeking a Manager, Clinical Operations Site Management. You will oversee assigned CRAs, ensure workflow efficiency, and optimize utilization while maintaining compliance with FDA, ICH, and HIPAA standards.

The role emphasizes interviewing, onboarding, training, on-site mentoring, performance reviews, CAPAs, timecard oversight, and collaboration with Directors of Clinical Operations to uphold quality and project success.

Qualifications

• Bachelor's degree in life sciences required.
• Six or more years of clinical research experience as a CRA or similar.
• Experience with EDC systems and CRO environments preferred.

Responsibilities

• Interview and select CRA/IHCRA candidates and onboard permanent staff.
• Provide on-site mentoring and ensure training for visits and billable monitoring.
• Monitor quality metrics and review site visit reports and TMF readiness.
• Review timecards and approve contractor hours and expenses.
• Conduct performance appraisals and manage employee relations.
• Assist with CAPAs and coordinate with Directors of Clinical Operations.
• Approve PTO requests and manage non-billable expenses.

Skills

Communication skills

Project management

Attention to detail

Clinical research knowledge

Mentoring & leadership

Education

Bachelor's degree in biosciences or related field

Two-year college degree or equivalent (nursing exception)

Six years of clinical research experience or more

Tools

InForm

Medidata

Microsoft Word

Microsoft Excel

Outlook

Job description

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands‑on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

What the Manager, Clinical Operations Site Management does at Worldwide Clinical Trials

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.

What You Will Bring To The Role

• 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

Your Experience

• 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

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation.

The 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

The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it 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. Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage.

We love knowing that someone is going to have a better life because of the work we do.

To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.