Acts as the operational lead for a program, plans program-level risk mitigation strategies
Develops, reviews and/or revises study specific documents: Informed Consent Forms, study plans (e.g., Clinical Monitoring Plan, Risk Management Plan, Laboratory Manual, IMP/Pharmacy Manual, etc.), Case Report Forms, monitoring tools and other study documents including communications, and newsletters
Oversees ESP personnel in the development and implementation of study/program-related documents and activities
Ensures consistency in ESP execution and reporting across related studies
Communicates and coordinates program-related activities across all relevant cross-functional areas
Assists in developing training program and training new team members on corporate culture, expectations and departmental/organizational policies and procedures
Leads program-related team and cross-function meetings, teleconferences, and study specific trainings
Develops and maintains current program level training materials, program slide updates for management
Mentoring and managing other CRAs or Clinical Trial Assistants
Applies critical thinking while monitoring – reviews and verifies source data to ensure quality data reporting, safety events in the electronica data capture (EDC) and safety databases
Performs Pre-Study, Initiation, Interim/Routine and Close-out visits of investigator sites (on-site and remote), including co-monitoring and oversight monitoring
Performs Investigational Medicinal Product (IMP) review and accountability and ensuring Pharmacy facility and staff adhere to the IMP/Pharmacy Manual and product requirements
Ensures all clinical site personnel are trained on the protocol and study specific requirements, and adheres to FDA regulations, International Council for Harmonisation (ICH)/Good Clinical Practice (GCP) guidelines
Ensures any identified non-compliance issues are addressed, clearly communicated, documented and escalated
Utilizes EDC reports to perform central monitoring and data cleaning
Collaborates with Data Management and cross-function teams focusing on data integrity, trending & consistency across the program
Presents program level updates to management and team
Assists VP, Clinical Operations, with departmental resourcing and budgeting activities.
Adheres to SOPs, FDA regulations, ICH/GCP guidelines and ensures program activities are conducted following the protocol, ICH, GCP and all applicable global regulatory requirements
Coordinates and/or supports program level inspection readiness strategies in preparation for and defense of regulatory filings.
Qualifications:
Educational Background:
BA / BS / RN: With 8 or more years of relevant clinical or related experience in life sciences.
MA / MS / PharmD / PhD: With 6 or more years of relevant clinical or related experience in life sciences.
Experience:
A minimum of 4 years' cross-functional study management or related leadership experience in life sciences, including multiple years' experience managing study management or project teams.
Experience managing direct reports.
Proven ability to successfully start-up, manage, and close out clinical studies, including authoring clinical study and regulatory documentation and SOPs.
Experience in gastroenterology and respiratory products preferred.
Skills and Competencies:
Advanced knowledge of one or more disease or therapeutic areas, as evidenced by independence in designing, implementing, and managing study team plans, deliverables, and resource management.
Job Identifier: #4851
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance and Research
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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