What are the responsibilities and job description for the Senior Clinical Trials Manager position at Clinical Dynamix, Inc.?
How you’ll make an impact:
- Contribute to the planning, implementation and execution of a global clinical trial
- Responsible for management of vendors to support clinical trial execution
- Plan, execute, and lead study-specific meetings (e.g., internal core team meetings, investigator meetings, etc), as needed
- Provide input for the design of the Informed Consent Form(s), eCRFs, monitoring conventions, edit checks, etc.
- Provide study-specific training and leadership to clinical research staff, CRO, CRAs, sites and other contract personnel.
- Manage study timelines and metrics to ensure completion of study deliverables
- Support site selection, qualification, initiation, and monitoring activities.
- Review monitoring reports to ensure quality and resolution of site-related issues.
- Ensure timely enrollment and data collection at clinical trial sites.
- Collaborate with the data management team to ensure data integrity and timely database lock.
- Review and analyze clinical trial data to identify trends and potential issues.
- Ensure tracking and review of protocol deviations and assess impact on study data
- Develop relationships with investigators and site staff
- Work closely with CRO and Medical Monitor to ensure safety and efficacy data appropriately summarized to facilitate review.
- Work closely with translational medicine team to ensure appropriate incorporation of bioanalytical sampling plan into clinical protocols and relevant data output of the trial is provided to functional groups for review.
- Maintain accurate and complete trial documentation.
- Proactively identify and resolve clinical project issues.
Skills and experience you’ll bring:
- Bachelor of Science in Life Sciences and 5 years as a Senior Clinical Trial Manager in the biotech/pharmaceutical industry.
- Experience working on large, global, complex phase 2b/3 or late stage trials. Respiratory or Immunology experience highly preferred.
- Broad knowledge of regulatory and ICH GCP guidelines, HIPAA, Protection of Human Research Subjects.
- Strong project management skills with the ability to manage multiple trials simultaneously.
- Excellent problem-solving, leadership, and communication skills.
- Ability to work in a fast-paced, dynamic environment with cross-functional teams.