Precision Medicine Group
Clinical Trial Manager/ Senior Clinical Trial Manager
Remote, United States · Senior
Sponsorship not specified$111k-$201kDetected 34 days ago
GCPExcelClinical TrialsClinical ResearchResearchCommunicationPublic Speaking
About the role
- Essential functions of the job include but are not limited to:
- Primary clinical point of contact with the client
- Identify potential risks to the enrollment targets based on feasibility analysis and site's contracted commitment
Responsibilities
- Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies per defined scope of work and ensures that clinical studies are conducted in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and all applicable regulatory requirements.
- Collaborate with PM on monthly invoicing and variance management of clinical budget
- Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials)
- Identify and develop training needs for CRAs and third-party vendors specific to the study, protocol and practices including presenting these at Investigator Meetings and Study Kick-off meetings
- Generate potential site list from key stakeholders and drive site feasibility process
- Develop and finalize the country recruitment/retention strategy
- Develop timely and effective communication and good working relationships with investigators and study team to ensure effective and timely feasibility, site start up, enrollment, maintenance and close out procedures
- Support in planning and conducting investigator meetings
- Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments as applicable
- Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables
Requirements
- Minimum Required:
- Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience
- Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
- Ability to travel domestically and internationally including overnight stays
- Working knowledge of clinical management techniques and tools
- Direct work experience in a cross-functional environment
- Proven experience in functional management including proven experience in delegating while fostering cohesive team dynamics
- Proven experience in planning, risk management and change management
- In depth proven experience in pharmaceutical and/or device research required
- Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role.
Nice to have
- Advanced degree preferred
Compensation
- Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role.
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