Overview
The Senior Clinical Trail Manager has a high level of core competencies and technical skills that are applied within the management of clinical programs leading to registrational submissions of Biologic License Applications (BLAs).
The Senior Clinical Trial Manager position is a member of a cross-functional clinical team that has 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
- Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
- Perform miscellaneous duties as assigned.
Required Education, Skills, and Knowledge
- Bachelor’s degree with 6+ years of pharmaceutical or biotech-related/clinical research, oncology, or research experience
- Demonstrated experience in core and technical aspects of designing, initiating, and managing phase 1-4 clinical trials.
- Demonstrated experience in management of CROs, in vendor selection.
- Possessing excellent interpersonal and communication skills, with demonstrated leadership attributes.
- Positioned as a subject matter expert in application of US and Global Regulations and Guidance (SOPs, ICH-GCP, FDA-CFR, ethical standards)
- Broad scope experience in data collection, monitoring, cleaning, and analysis throughout clinical development (Phase 1-4)
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
Physical Demands and Activities Required
- Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
- Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
- Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
- This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
- Must be able to communicate with others to exchange information.
Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines
Work Environment
This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.
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