Sr. Project Manager, Clinical
Manage project planning and communication with the study team to ensure the conduct of clinical studies in accordance with good clinical practices, MicroVention Standard Operating Procedures, and all applicable (e.g. FDA) regulations and guidelines. Pivotal role designing and executing clinical research programs to enable successful transition to clinical development. Involved in the design, conduct, data management, and interpretation and reporting of clinical trials. Ensure all clinical studies operate to the highest ethical and safety standards and in compliance with company, GCP and regulatory requirements. Job duties:
- Contribute to the preparation of study documentation such as protocols, amendments, Case Report Forms, SOPs, investigational plans, Investigator’s manual, and study reports.
- Collect and process regulatory documents and correspondence.
- Prepare and ensure accuracy for MV studies on clinicaltrials.gov.
- Assume other responsibilities under the direction of the Clinical Research department.
- Perform additional duties as assigned
- BS/BA degree in Life Sciences or related field.
- Minimum five (5) years of direct clinical research project management experience, preferably in the medical device industry.
- Demonstrated experience in project management.
- In depth understanding of clinical studies.
- Knowledge of clinical trial design, management, terminology, and related GCP and regulatory requirements.
- Proficiency in the logistics of clinical study setup and management, database oversight, and the tracking of study metrics.
- Strong verbal and written communication skills.
- Good MS office skills to include Word and Excel.
- Experience in designing, monitoring, and implementing clinical trials and interpreting trial results, including understanding of biostatistics and safety reporting.
- Able to handle multiple tasks efficiently and consistently, meeting deadlines.
- IDE clinical experience is strongly preferred, as well as global experience.
- Ability to maintain strict confidentiality