Clinical Trial Manager
About The Position
The Clinical Trial Manager has operations experience in the biotech or biopharmaceutical arena and applies core competencies and technical skills to manage clinical programs leading to Biologic License Application (BLA) submissions. The role joins a cross-functional clinical team and contributes to programs in therapeutic indications with unmet medical need and orphan disease status. The Clinical Trial Manager supports operational execution of clinical studies from initial synopsis through final deliverables, including database hard-lock, final tables, listings, and figures (TLFs), and the clinical study report (CSR). The role manages study implementation and conduct, budgets, milestones, timelines, scope, resources, vendors, quality, safety, and compliance. It oversees cross-functional study teams, manages risks, assesses trial data, supervises vendors, protects data integrity, and reports progress to senior management. The position also requires awareness of regulatory developments and the competitive landscape, and the ability to adapt study plans and resolve challenges. The job operates in a professional or remote office environment and involves operating standard office equipment and keyboards. The stated physical demands include prolonged sitting or standing, movement around an office, occasional exertion of up to 10 pounds (or negligible force more frequently), visual acuity for computer work and reading, repetitive wrist, hand, or finger movements, and communication with others. Mental demands include clear and conceptual thinking, judgment, troubleshooting, problem-solving, analysis, discretion, handling work-related stress and multiple priorities, and meeting deadlines.
Requirements
- Bachelor’s degree.
- At least 5 years of pharmaceutical- or biotech-related, clinical research, oncology, or research experience, including at least 1 year as a Clinical Trial Manager.
- Demonstrated experience in core and technical aspects of designing, initiating, and managing Phase 1–4 clinical trials.
- Demonstrated experience managing CROs and selecting vendors.
- Excellent interpersonal and communication skills, with demonstrated leadership attributes.
- Subject matter expertise in applying U.S. and global regulations and guidance, including SOPs, ICH-GCP, FDA-CFR, and ethical standards.
- Broad experience in data collection, monitoring, cleaning, and analysis throughout clinical development (Phase 1–4).
Responsibilities
- Support operational execution of clinical studies across one or more programs, from initial study synopsis through final deliverables such as database hard-lock, final TLFs, and CSR.
- Manage study implementation, on-time execution, and conduct, including budgets, milestones, timelines, scope, resources, and vendor selection, while maintaining quality, safety, and compliance.
- Oversee cross-functional study team members to ensure clinical programs are initiated and executed within approved budgets and timelines.
- Manage and mitigate risks, prioritize competing tasks and issues, and ensure program and study objectives are accomplished.
- Lead vendor identification, qualification, and selection, and oversee systems setup and management, including EDC, IWRS, central laboratories, and specialty services such as ePRO and eDiary.
- Support and deliver the trial endgame, including data and statistical analyses.
- Critically assess data to identify trends and outliers and direct resources to resolve problems early.
- Review and supervise multifunctional vendor groups, including clinical operations, data management, and biometrics.
- Ensure data integrity through routine data reviews, query resolution, and consistency checks, including checks for independent DMC/DSC.
- Track and communicate program and study progress to senior management, creating and updating detailed dashboards and trackers.
- Monitor the competitive landscape and changes to regulations and guidance, assess their impact on clinical projects, and make modifications as necessary.
- Approach challenges creatively and resolve problems to optimize clinical trial conduct.
- Adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
- Perform miscellaneous duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
