Clinical Trial Lead, Clinical Management

Title for this position: Clinical Trial Lead, Clinical Management
Onsite: yes, remote to start
Duration: 12+ months
This position is located in Princeton, NJ

• Acts as the operational lead for assigned domestic and global protocol(s) to ensure proper conduct and timely completion of project(s).
• Contributes to the development and implementation of Clinical Trial strategy.
• Contributes to the development of protocol outlines, protocols, amendments, and Case Report Forms (CRFs), as assigned.
• Serves as primary ESP contact for protocol related issues.
• Oversees the ESP in its conduct of the day-to-day operations of assigned protocol(s), including:

• Development of ICFs and other study-related documents.
• Trial planning.
• Recruitment strategy.
• Site selection.
• Trial execution according to plan.
• Management and leadership of team meetings.
• Trial-related reporting (enrollment, monitoring, regulatory documents, etc.)
• Trend analysis and risk mitigation.

• Ensures accuracy and completeness of study-related tracking (enrollment, monitoring, regulatory documents, etc.)
• Provides routine trial status updates.
• Reviews and analyzes the data from tables and listings.
• Trains the ESP in OPDC clinical data review.
• Contributes to Clinical Study Reports (CSRs).
• Acts as a resource to the ESP staff to identify problems and propose solutions to maintain projects within designated timelines and budgets.
• Responsible for the quality of the preparation, presentation, issue identification, and follow-up for all portions of investigator meetings.
• Identifies and escalates potential serious compliance issues and assists in the development of action plans.
• Co-ordinates training programs for Clinical Trial staff and ESPs prior and during study conduct.
• Communicates and coordinates study-related activities across all relevant cross-functional areas.
• Ensures that assigned studies are conducted following the protocol, ICH, GCP and all applicable global regulatory requirements.
• Conducts Monitoring Oversight Visits.
• Approves selection of appropriate clinical staff by the ESP.
• Ensures communication and interaction within project team.
• Participates in process and continuous improvement initiatives as assigned.
• May serve in the Oversight Risk Management role as assigned.

• Performs regular reviews within the eSource and eSurveillance systems per the Oversight Risk Plan (ORP) and Integrated Data Review Plan (IDRP) to execute oversight and ensure quality performance throughout the life cycle of the trial.
• Tracks and analyzes data for trending, develops appropriate action plan for risk mitigation strategies and report outcomes (issues/trends) to the Clinical Trial team. Implements action plan for process improvement, as required.
• Analyzes qualitative and quantitative metrics from remote and onsite monitoring visits addressing and resolving issues through risk mitigation strategies.
• Performs and oversees assigned data reviews are being executed within the eSurveillance system in accordance with the trial specific IDRP.
• Implements the Oversight Risk Plan (ORP), including oversight of ESP activities for assigned trials.
• Implements and manages the Trial Master File (TMF) Plan for assigned trials.
• Oversees the setup, maintenance and archival of the TMF.
• Supports Clinical Trial Team (CTT) in preparation of internal and external audits, develops or assists in the implementation and management of CAPAs.
• Acts as main contact for the implementation of risk-based methodology and tools with key internal and external partners on assigned trials.
• Participates in User Acceptance Testing (UAT) for assigned trial to ensure technology integration is in alignment with the trial protocol.

• Performs other duties as assigned.

The Company is an equal opportunity employer and makes employment decisions on the basis of merit and business needs. The Company will consider all qualified applicants for employment without regard to race, color, religious creed, citizenship, national origin, ancestry, age, sex, sexual orientation, genetic information, physical or mental disability, veteran or marital status, or any other class protected by law. To comply with applicable laws ensuring equal employment opportunities to qualified individuals with a disability, the Company will make reasonable accommodations for the known physical or mental limitations of an otherwise qualified individual with a disability who is an applicant or an employee unless undue hardship to the Company would result.