Precision Oncology Clinical Trial Manager

Precision Oncology Clinical Trial Manager Capabilities:

Advanced Systems Management:

Expert proficiency in managing and optimizing Clinical Trial Management Systems (CTMS) and Quality Document Management Systems (QDMS) to ensure "single source of truth" data integrity.

• EDC & e

TMF Mastery:

Hands-on experience with Electronic Data Capture (EDC) and Electronic Trial Master File (eTMF) platforms, with a focus on real-time data review and identifying collection bottlenecks.

Digital Logistics:

Oversight of automated tracking for Investigational Product (IP), lab kits, and clinical supplies to ensure a lean and responsive supply chain.

Data-Driven Oversight:

Ability to synthesize complex trial data into actionable insights, moving from simple reporting to proactive trend analysis regarding patient recruitment and accrual projections.

Regulatory Intelligence:

Deep technical knowledge of FDA regulations, ICH-GCP guidelines, and the ability to proactively translate these into operational project plans.

• Precision Oncology Fluency-Understanding of biomarker-driven protocols and the technical nuances of oncology patient screening and enrollment.

Agile Project Management:

Proven ability to maintain and evolve a dynamic Project Management Plan, adapting to trial amendments and real-world clinical challenges in real-time.

Financial Tech Integration:

Proficiency in financial tracking tools to provide granular oversight of vendor invoices and site-specific billing activities.

Risk Mitigation:

Technical capability to serve as a first-line reviewer for Clinical Trial Monitoring reports, utilizing data to trigger and close out corrective action plans.

Operational Tasks:

• Collaborate with clinical trial sites: Establish and maintain strong relationships with clinicians, nurses, and other healthcare professionals at the clinical trial sites. Serve as a point of contact for clinical trial and operational questions for successful patient recruitment and treatment.
• Works closely with vendors and clinical trial sites to gather real-time data on patient recruitment, enrollment, treatment, and outcomes. Ensure that data is collected accurately and in accordance with the study protocol and regulatory requirements.
• Supports efforts to ensure compliance with all regulatory requirements and internal policies related to the conduct of clinical trials. Maintain accurate and up-to-date documentation of all communication and activities related to any questions or concerns shared regarding the clinical trials.
• Supports clinical trial document amendments by assisting in editing and finalization of documents for regulatory submissions.
• Participates in data reviews (coding, deviations, safety, etc.) to ensure effective and timely collection of clinical trial data.
• Participates as first line reviewer of Clinical Trial Monitoring reports and ensures corrective action plans are written and closed for action items identified.
• Maintains a current Project Management Plan for the Clinical Trial and modifies as needed.
• Works with financial team to provides tracking and oversight of invoices for Lantern supported clinical trials to ensure correct and timely billing of clinical trial site activities and vendors.
• Disseminates information for the clinician audience about clinical issues during emergencies, including updated clinical guidelines.
• Collects and compiles clinical inquiries to guide communication strategies (FAQs).
• Files Clinical Trial documents in the QDMS system in a timely manner.
• Conducts outreach and builds relationships with patient advocacy groups for clinical indications addressed in the clinical trials in an effort to better understand recruitment strategies and share information on our clinical trials.
• Other duties as required.

BASIC QUALIFICATIONS

• Bachelor's degree (Master of Public Health, RN, BSN or similar, preferred) and 5+ years of related communications experience in clinical or nursing environments.
• Previous experience in clinical research or healthcare industry preferred.
• Strong communication and interpersonal skills, especially in relationship building.
• Ability to work independently and as part of a team.
• Excellent organizational and time management skills.
• Knowledge of regulatory requirements governing clinical trials (e.

g., FDA regulations, ICH-GCP guidelines) is a plus. Confidential Page 1 of 2