Clinical Project Manager managing Class II and Class III medical device clinical trials for Cochlear. Leading teams and ensuring compliance with regulatory standards in a hybrid work environment.
About the role
- Scientist in Clinical Operations conducting clinical study activities. Collaborating on study materials and ensuring quality and integrity in clinical data.
Responsibilities
- Responsible for specific clinical/scientific activities on a single study or across multi e studies (e.g., medical monitoring, lab specimen tracking/reconciliation, adjudication support, preparation of meeting materials).
- Support development of Protocol and related study materials (e.g., ICF documents/amendments, data management deliverables).
- May interact with internal and external stakeholders (e.g., country operations, committees, vendors) in support of clinical study objectives.
- Support development of site and CRA training materials
- Prepare clinical narratives
- Collaborate cross-functionally to monitor clinical study data to ensure quality, completeness, and integrity of trial conduct.
- Participate in CRF design to ensures data collection is in alignment with the protocol.
Requirements
- Bachelor's Degree +2 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR Master's Degree +1 year of pharmaceutical, clinical drug development, project management, and/or medical field experience
- Degree in life sciences, preferred.
- Working knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
- Ability to manage multi e competing priorities with good planning, time management and prioritization skills
- Analytical skills with the ability to interpret clinical trial data and synthesize conclusions
- Interact with key stakeholders across department, division, and company.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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