Clinical Trial Manager

2 weeks ago

Bethesda, Maryland, United States Precision Medicine Group Full time
Radiopharmaceutical Clinical Trial Manager Job Summary

Precision Medicine Group is seeking a highly skilled Radiopharmaceutical Clinical Trial Manager to lead the planning, conduct, and oversight of clinical studies in the radiopharmaceutical space. As a key member of our clinical operations team, you will be responsible for ensuring that clinical studies are conducted in accordance with protocols, standard operating procedures, and regulatory requirements.

Key Responsibilities:
  • Collaborate with clients to develop and implement clinical trial strategies
  • Lead cross-functional teams to ensure timely and effective execution of clinical trials
  • Develop and maintain clinical trial documentation, including protocols, informed consent forms, and study manuals
  • Identify and mitigate risks to clinical trial timelines and budgets
  • Develop and implement country-specific recruitment and retention strategies
  • Build and maintain relationships with investigators and study teams to ensure effective communication and collaboration
  • Lead internal clinical team meetings and set expectations for clinical team members
  • Address CRA and site questions and maintain FAQ logs as necessary
  • Support planning and conducting investigator meetings
  • Review and approve IP release packages
  • Oversee submissions and approvals to Competent Authorities and IRB/Ethics Committees
  • Develop clinical monitoring strategies to ensure study timelines are met and quality deliverables are achieved
  • Generate and utilize metric reporting to ensure study progress and communicate issues to stakeholders
  • Responsible for eTMF implementation and management
  • Collaborate with PM, CRAs, and QA to develop CAPAs and implement timely closure
  • Accountable for assisting sites, internal staff, and CRAs with preparation for GCP audits
  • Work closely with PM for project-specific resourcing issues
  • Escalate pertinent CRA performance and site compliance issues when necessary
  • Collaborate with data management and CRAs to ensure data quality and compliance with data cleaning timelines
  • Manage processes for investigational product, including drug accountability and reconciliation
Requirements:
  • Bachelor's degree or equivalent combination of education/experience in science or health-related field
  • Minimum of 5 years of clinical research experience or proven competencies for the position
  • Significant clinical monitoring experience in radiopharmaceuticals and/or radiolabeling
  • Ability to travel domestically and internationally, including overnight stays
Preferred Qualifications:
  • Advanced degree
  • Experience with radiopharmaceuticals or radiolabeling
Competencies:
  • Demonstrates mastery knowledge of ICH-GCP, relevant Precision SOPs, and regulatory guidance
  • Experience in radiopharmaceuticals/radiolabeling
  • Working knowledge of clinical management techniques and tools
  • Direct work experience in a cross-functional environment
  • Proven experience in functional management, including delegating and fostering cohesive team dynamics
  • Proven experience in planning, risk management, and change management
  • High level of integrity and ability to inspire and demand the highest standards from a professional and ethical perspective
  • Ability to lead and inspire excellence within a team
  • Ability to create an environment where employees have a sense of ownership, leading to increases in productivity and efficiency
  • Results-oriented, accountable, motivated, and flexible
  • Excellent time management, negotiation, critical thinking, decision-making, analytical, and interpersonal skills
  • Excellent presentation, verbal, and written communication skills
  • In-depth proven experience in pharmaceutical and/or device research required
  • Demonstrated successful independent negotiation and conflict management strategies

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