- Makes clinical research strategy recommendations to company. Assists CEO in short/long- term project planning.
- Develop and implement effective clinical study protocols for company products.
- Review and approve clinical documents (e.g., CRF’s, IB, protocol/informed consent, training materials)
- Participate in review/execution of Clinical Trial Agreements and study site budgets.
- Manage and participate in monitoring/co-monitoring and/or audit clinical studies/investigative sites and CRFs to ensure data quality and integrity.
- Monitor ongoing compliance to study protocols, FDA regulations, and IRB requirements.
- Reviews and provides preliminary approval of monitoring reports to ensure that potential issues are identified, escalated as necessary and appropriately resolved.
- Review set of Global SOP’s; identify gaps that require additional documentation. Responsible for ensuring compliance with SOPs and guidelines for Clinical Operations, FDA regulations and current ICH GCP guidelines across Global sites.
- Work with CEO and R&D to identify and evaluate investigators and clinical sites.
- Manage investigative sites, including interviewing/screening investigators and monitoring/auditing regulatory documents to ensure compliance with company SOPs, GCPs, and applicable regulatory requirements
- Oversee development and maintenance of computerized data collection systems.
- Respond to audits conducted at selected study sites.
- Assists in the identification, assessment and management/oversight of contracts, CROs, vendors, and program-related consultants.
- Organizes and participates in study team and investigator meetings.
- Coordinates all clinical budgets ensuring that adequate resources are available to accomplish necessary tasks.
- Attends Product Team meetings and design review meetings to ensure adequate clinical direction is provided.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- 10 + years clinical operations experience and/or training.
- Oncology Experience required
- Previous experience in interacting with key decision makers
- Well-rounded mix of experience in both large, well-established pharmaceutical/biotechnology companies and early stage startups
- Comprehensive working knowledge of FDA regulations and procedures
- Ability to thrive in dynamic early stage start-up business environments
- Ability to build and lead teams
- Ability to establish credibility with a broad range of constituents inside and outside the company
- Steadfast leadership that can be counted on in both good and challenging times
- Self-confidence and a readiness to stand for beliefs balanced by the maturity to maintain appropriate level of flexibility
- Ability and willingness to “roll up the sleeves” and become actively engaged in tactical execution
- Ability to travel upwards to 50%
Position Type: Full-time
Reports to: CEO
Travel Required: As needed
Please contact Laura at email@example.com