Job Description

A Clinical Project Manager will work with the executive teams of Global Clinical Operations and Clinical
Development to execute clinical research studies through Contract Research Organizations (CROs). The Clinical role is the primary point of contact for the operational execution of the study and is accountable for study delivery through oversight of the chosen CRO(s) and interface with internal resources. Perform job functions in accordance with all applicable Standard Operating Procedures (SOP), federal and regional laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes.

Role & Responsibilities

• Acting as the primary point of contact for the operational execution of assigned clinical Phase I-IV.
• Delivery of study through oversight of chosen CRO(s) and interface with internal resources for appropriate facets of the operational execution and delivery.
• Oversight of day to day operational activities of clinical projects.
• Ownership of study risk management plan including timely communication of study progress, risks and risk mitigation strategy to Program Leadership.
• Tracking study progress against the study schedule as detailed in Program Plans.
• Assist Clinical Operations Program Lead with managing study costs against actual budget and providing budget forecast data as requested
• Contribution to and review of key clinical documents, in close collaboration with other line functions (e.g. Regulatory Affairs, Clinical Supplies, Clinical Research, Pharmacovigilance)
• Providing input to the preparation of regulatory authority submission documents, e.g. IND, CTA, ANDA, MAA and supporting regulatory defense activities as required.
• Assisting regulatory with acquiring essential documents required for continual and current IND updates.
• Responsible for filing and maintenance of Study/Project documents, specifically, but not limited to the Trial Master File (TMF). 11. Assist with the tracking study status to study assigned Key Performance Indicators (KPIs).
• Assist with the organization of governance type lessons learned as requested. 13. Organizing, inputting and maintaining all study related public disclosures. 14. Perform other duties as assigned.

Required Skills and Knowledge

Must

• Demonstrated strong communication, influencing and interpersonal skills.
• Reliable, proactive team player with a proven track record for delivery
• Good organization skills, attention to detail, ability to work as part of a global team and the ability to manage multiple tasks is required.
• Requires strong understanding of the drug development process
• ICH GCP Practitioner and working knowledge of other associated regulations, guidelines and industry standards for clinical trials
• Comprehensive operational experience in clinical research:
  • Experience of Monitoring Clinical Studies
  • Experience of vendor / CRO Management
  • Experience in managing schedules, budget, risk and processes with a clinical trial setting.
• Knowledge of medical terminology
• Proficient in PC applications (Excel, Microsoft Word, etc.).
• Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis. Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.
• Ability to read and interpret comprehensive and intricate research documents.
• Ability to write scientific reports and technical correspondence.
• Ability to work with executives and communicate abstract concepts.
• Ability to present to a high level of the organization and groups outside of the organization.
• Minimum of a Bachelor’s Degree in a Scientific Discipline or equivalent and 1 year experience in a clinical project management field within the Pharmaceutical or CRO industry.
• A combination of experience and/or education will be taken into consideration.

Preferable

• Experience of operating within Global, Multidisciplinary Team
• Experience of operational delivery within multiple Disease areas.