Clinical Affairs, Sr. Proj/Prog Manager
To oversee the implementation and running of multiple clinical studies for the purpose of obtaining Regulatory approvals for new indications or products, as well as support current Company preservation products to support the process of obtaining solid clinical data to support the publication of peer-reviewed manuscripts, meeting presentations, and white papers.
- Participate on cross functional core project team to ensure clinical deliverables are aligned with Business Unit and/or Corporate objectives
- Support product launch activities as needed
- Understanding of competitive landscapes for assigned products
- Demonstrate understanding of Business Unit general business functions, products, and procedures
- Conducting clinical research programs in accordance with approved project plan, compliance to company standard operating procedures, and applicable regulations
- Clinical project planning and management in keeping with the global corporate directive and strategic goals
- Overall project budget and timeline development and execute accordingly
- Able to adapt and execute should strategic goals shift during the life of the project
- Experience in detecting project risks and capable of addressing with mitigation plan and alternative solutions
- Provide management level representation during audits and inspections
- Develop project-tracking systems and provide accurate progress reports on assigned studies and sites
- Oversee and contribute to the development of key study documents including, but not limited to study protocols and protocol synopses, protocol amendments, study plans, and procedure manuals, project tools, informed consent forms, and clinical study reports
- Develop appropriate budgets, negotiate contracts, and prepare agreements, in collaboration with the Contract Specialist, for the conduct of clinical trials at investigative centers
- Prepare data outputs for written and verbal presentations of study data for FDA submissions, as well as CE-marking
- Manage the handling of clinical study-related questions from doctors, patients, and sales force, as appropriate
- Promote good communication within the clinical department, as well as with other Company department members
- Collaborate with R&D, marketing, and other departments to ensure alignment with project goals, as appropriate
- Review of all promotional material for compliance
- Provide input and support for post-clinical activities and market launch of products
- Evaluate and triage investigator-sponsored research proposals in preparation for committee review
- Ensure clinical research programs are conducted in accordance with company standard operating procedures (SOPs/DOPs), Good Clinical Practice (GCP), and specific country regulations, as applicable
- Regularly interact with senior management and prepare periodic reports as required for management review.
- Minimum Qualifications:
- 5+ Yrs. Exp BS/BA
- Preferred Qualifications:
- CCRP or CCRA certified or equiv.
- Demonstrated Leadership abilities
- Master’s degree
- Austin location or remote
EOE AA M/F/VET/Disability
All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state, or local laws.