Manager, Clinical Operations Site Management

Worldwide; North Carolina; Hybrid; USD 97,000 - 222,000; Full time

Benefits offered by this job

Competitive benefits package

Job summary

Worldwide Clinical Trials is seeking a Manager, Clinical Operations Site Management to lead a team of CRAs/IHCRAs, ensure training, onboarding, and ongoing performance across multiple studies. You will establish clear communication, review quality metrics, and manage resource allocation to meet project goals.

The role requires deep understanding of clinical research, FDA/ICH/HIPAA regulations, and hands-on experience with EDC systems like InForm and Medidata.

Qualifications

• Understanding of clinical research principles and data collection/editing.
• Knowledge of EDC software InForm and Medidata.
• Familiarity with FDA, ICH, and HIPAA regulations.
• Experience with SOPs and therapeutic area knowledge.

Responsibilities

• Manage and develop CRAs/IHCRAs, ensuring performance and onboarding.
• Provide on-site mentoring and regular communication with team.
• Monitor quality metrics like site visits, source data verification, and trial master file readiness.
• Review timecards and approve contractor hours.
• Conduct performance appraisals and implement CAPAs as needed.

Skills

Communication skills

Planning & organization

Interpersonal skills

Problem solving

Attention to detail

Clinical research knowledge

EDC software

FDA/ICH/HIPAA knowledge

SOPs knowledge

Therapeutic knowledge

MS Word/Excel/Outlook

Education

Bachelor's degree in biological/health sciences

Two-year college credential (or equivalent)

Experience as CRA/clinical research role

Tools

InForm

Medidata

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

## Manager, Clinical Operations Site ManagementApply: Remote: Research Triangle Park, North Carolina: Full time: Posted Today: JR102936Who we areWe’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 WorldwideWe 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 expensesThe 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 requiredPromotion 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 - $222,000.00The 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.