Worldwide Clinical Trials

Manager, Clinical Operations Site Management

Worldwide Clinical Trials$97K — $222K *
US-AnywhereRemote in Durham, NC
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in biological, physical, health, pharmacy, or related sciences with 6 years of clinical research experience, or equivalent education and 7 years of experience.
  • 8 years of clinical research experience in a relevant position with a pharmaceutical or biotechnology company.
  • At least 2 years of management experience.
  • Ability to travel and possess a valid passport.
  • Strong knowledge of FDA regulations, ICH guidelines, and HIPAA.

Responsibilities

  • Interview and select CRA/IHCRA candidates.
  • Ensure consistent onboarding and training for CRAs/IHCRAs.
  • Mentor CRAs through site visits and observations.
  • Establish regular communication to review quality metrics.
  • Manage the performance and quality of CRAs/IHCRAs.
  • Address performance issues and serve as a point of escalation.
  • Conduct performance appraisals and manage employee relations.

Benefits

  • Commitment to an inclusive and equitable workplace.
  • Transparent compensation practices and pay equity.
  • Comprehensive benefits package depending on location.
Full Job Description

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 ! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

About Worldwide Clinical Trials

Worldwide Clinical Trials is a global contract research organization (CRO) that provides clinical research services to pharmaceutical and biotechnology companies. They specialize in early phase development, late phase development, and full-service clinical research. Worldwide Clinical Trials has experience in a wide range of therapeutic areas, including oncology, neuroscience, and infectious diseases. They are committed to providing high-quality, efficient, and cost-effective services to their clients.
Learn more about Worldwide Clinical Trials
Size
1,500 employees
Industry
Founded
1986

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