Clinical Affairs, Senior (Study Operations) - Transplant Diagnostic

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Clinical Affairs, Senior – Study Operations

In this role, you will have the unique opportunity to lead clinical study operations to include clinical trial budgeting and study management activities. You will collaborate with cross-functional teams to support clinical planning and study execution Additionally, you will analyze clinical affairs operations, identifying areas for improvement and implementing corrective measures.

 

Responsibilities:

• Manage overall clinical study budgets; negotiation and managment of budgets with clinical sites, vendors, and CROs (e.g. CTAs, PO and invoicing)
• Support department leadership to determine resource allocation and financial forecasting for clinical studies.
• Interact with investigative sites, vendors, and other functional areas to ensure successful execution of clinical studies.
• Coordinate the planning of clinical studies to ensure that deliverables are completed on time and within budget
• Develop and lead internal clinical project database.
• Update and/or generate internal Standard Operating Procedures (SOPs) to ensure GCP compliance
• Support clinical study management activities to include, IRB/EC submission and approval activities and generating clinical site documentation in compliance to trial protocols.
• Participate on cross functional core project teams to ensure clinical deliverables are
  aligned with Business objectives.

 

Qualifications:

• Bachelor's degree in Science with at least 5+ years of hands-on involvement in clinical research, demonstrating a strong history of effectively managing budgets for clinical trials.
• Strong working knowledge of Good Clinical Practices (GCP), FDA and EU regulations, and current industry practices related to the conduct of clinical trials.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with multidisciplinary teams
• Organized and attentive to detail, with a strong commitment to achieving high-quality outcomes
• Strong analytical and problem-solving abilities
• Ability to work effectively in a fast-paced and dynamic environment
• Proficient in applying tools for managing clinical trials (e.g. eTMF, EDC).