Home Health Study Manager

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Oversee, manage, and document all activities related to study management, ensuring adherence to project plans and timelines.

• Provide training to designated staff, including subcontracted personnel, ensuring high-quality service delivery.

• Offer assistance and direction to all team members, including regular teleconferences to discuss progress, timelines, issue resolution, and information exchange.

• Communicate with relevant staff to guarantee that tasks are scheduled and completed within the required timelines.

• Assess study documentation for thoroughness, accuracy, and timeliness, addressing any gaps or inaccuracies as necessary.

• Ensure that study information is consistently updated and that reports are reviewed and distributed to the relevant stakeholders within the expected timeframes.

• Gather information to address inquiries from all stakeholders.

• Assist both internal and external team members in their efforts to support the study.

• Engage in and lead reviews with the study team.

• Serve as the intermediary between the sponsor, CRO, investigative site staff, laboratory, pharmacy, and other involved personnel.

• Represent the department competently and professionally during project calls, webinars, teleconferences, and meetings.

• Adhere to ICH/GCP, IATA, HIPAA, and other relevant regulations, policies, and procedures.

• Ensure that all study deliverables and scheduled study visits are completed punctually, with documentation being timely, complete, and accurate, and lab samples being evaluable.

⛳️ Requirements

• Minimum of 2 years of experience as a Clinical Research Coordinator, Clinical Research Associate, or in a comparable clinical research position, focusing on study startup, operational tasks, and study closeout processes.

• Outstanding attention to detail and organizational abilities, with a proven capacity to manage multiple priorities and complex study activities simultaneously.

• Strong problem-solving capabilities, with the ability to quickly evaluate situations, identify solutions, and address operational issues.

• Knowledge of laboratory procedures (preferred).

• Bachelor's degree, ideally in life sciences, healthcare, or a related field.

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.