Exciting new opportunity in Princeton, NJ for a Clinical Trial Manager!!
Must have recent RWE experience (within the last 3 years) Phase IV experience
The Clinical Trial Manager is a proactive leader who will plan, implement and oversee an assigned clinical study. This person will be responsible for managing day-to-day activities including trial start-up, conduct, and closeout activities as well as management of vendors. This person will partner with other functional leaders to develop study-specific strategies and solutions.
- Manage study operational plans, CRAs, project timelines, quality of deliverables, and approved trial budgets through the life of assigned trials.
- Participate in selection of vendors.
- Utilization of external data sources to establish a rationale for site selection
- Maintain frequent and meaningful contact with internal and external stakeholders to assess performance and provide guidance.
- Author, review, and refine clinical operations plans and documents.
- Develop and manage study timelines.
- Assessment and interpretation of study metrics followed by action plan development and follow-through
- Proactively identify project risks and resolutions.
- Oversee clinical trial site adherence to pertinent regulations through review of monitoring visit reports, CQA-GCP audit reports, communications with investigators, study site personnel, CRAs and other third party personnel.
- Identify and provide solutions to clinical trial issues and/or risks.
- Work closely with other teams in the organization (e.g. Quality Assurance, Regulatory Affairs) to achieve study objectives.
- Ensure the Trial Master File is actively maintained and inspection ready.
- Contribute to department process improvement activities.
- Ensure that the assigned clinical trials are conducted in accordance with internal Standard Operating Procedures, Good Clinical Practice regulations as well as applicable country regulations.
- Minimum of 5 years relevant pharmaceutical industry experience.
- Must have recent RWE experience
- Appreciation of and experience with FDA, ICH, and GCP guidelines and quality requirements in the conduct of trials.
- Excellent interpersonal, oral and written communication skills.
- Excellent planning and organizational skills with effective time management.
- Excellent presentation skills.
- Flexibility to change.
- Ability to negotiate and influence with diplomacy in order to achieve results.
- Experience in the study therapeutic indication/area preferred.
- Experience working in both the Sponsor and CRO environments preferred
- Willingness to travel required
- Proficiency in Microsoft Office.
- Proficiency with IxRS, CTMS and EDC systems.
Job Type: Contract
- Temporarily due to COVID-19