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Clinical Trial Manager
1 month ago
Candidate must be competent in all aspects of clinical trial operations including but not limited to ethics committee submissions and approvals, study start-ups and close-out procedures, consenting process, deviation and adverse event reporting and documentation, data collection, source document development, query resolution, and investigational drug accountability processes and procedures.
Responsibilities:
- Lead research team and support staff including mentoring and training of new hires
- Reviews new protocols and meets with site selection contact to determine site feasibility
- Assigns new studies to appropriate research staff members
- Ensures all research staff has completed required trainings and trainings are up to date
- Conducts new study protocol/procedures review and training via presentation with the site staff prior to each new trial start up
- Develops and negotiates trial budgets and terms of contracts
- Ensures exceptional implementation of study protocols while strictly adhering to good clinical practice guidelines and site-specific SOPs
- Able to identify and resolve study related problems
- Ensures timelines are being met effectively and accurately to meet sponsor expectations
- Can step in to perform clinical trial duties when necessary due to staff turnover
- Ensures legal and regulatory compliance
- Identifies inefficiencies in staff study related conduct or site resources and implements changes to improve
- When appropriate, develops quality assurance methods and implements
- Interacts with pharmaceutical trial sponsors, CROs, related vendors and site monitors
- Prepares and presents monthly and annual status reports to site investigator
- May be required to attend occasional off-site meetings
Qualifications:
- Minimum of 3-5 years of clinical trial management experience with bachelors degree in science or related field. Masters degree preferred.
- Strong knowledge of GCP/ICH guidelines and regulatory (ethics committee) requirements.
- Requires excellent written and verbal communication and time management skills.
- Must be detail oriented and able to manage multiple studies and tasks simultaneously.
- Compensation commiserate with degree and experience.
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