Clinical Trial Manager

Overview

The Clinical Trial Manager has operations experience within the biotech/biopharma arena. This individual has a high level of core competencies and technical skills to be applied within the management of clinical programs leading to registrational submissions of Biologic License Applications (BLAs).

The Clinical Trial Manager position is an opportunity for an individual to join a cross-functional clinical team having high-visible and dynamic input in a therapeutic indication of unmet medical need and orphan disease status.

Essential Functions and Responsibilities

• Support the overall operational execution of clinical studies on one or more clinical programs from initial study synopsis through final project deliverables (ie, database hard-lock, final TLFs, CSR, etc.)
• Manage the implementation, on-time execution and conduct of clinical studies; including the development of budget items, milestones and timelines, in addition to scope and management of resources (including vendor selection). All leading to overall quality, safety, and compliance throughout the duration of the clinical studies and program.
• Oversight of cross-functional study team members to ensure initiation and execution of the clinical program within approved budget and timelines
• Risk management and mitigation including prioritization of competing tasks and issues to ensure program/study objectives are successfully accomplished.
• Lead role in vendor identification/qualification/selection, systems set-up/management including EDC, IWRS, Central Laboratories, specialty services (ePRO, eDiary, etc.)
• Understanding of how to support and deliver the trial endgame, which is the data and statistical analyses
• Critically assess data to detect trends and outliers to efficiently direct resources and attention to correct problems early
• Ability to critically review and supervise a multifunctional vendor groups including clinical operations, data management and biometrics
• Ensure data integrity through routine data reviews, query and resolution, consistency checks both internally and for independent DMC/DSC
• Effectively tracks and communicate program/study progress to Senior Management with ability to create and update detailed dashboards and trackers
• Awareness of competitive landscape, changing regulations and guidance with ability to assess the impact on clinical projects and make modifications as necessary
• Ability to creatively approach challenges and problem resolution to optimize the conduct of clinical trials