Role: Clinical Project Manager
Location: Santa Clara, CA
Duration: 12 MonthsPosition Overview:
We are seeking a highly skilled Clinical Trial Manager to oversee and manage the operational aspects of our clinical trials. This role involves working closely with project teams to ensure compliance with standard operating procedures (SOP), good clinical practice (GCP), and relevant country regulations. The Clinical Trial Manager will be responsible for the development of clinical documents, management of clinical study activities, and effective communication with cross-functional teams.
Key Responsibilities
- Oversee and resolve operational aspects of clinical trials in collaboration with project teams, adhering to SOPs, GCP, and specific country regulations.
- Develop and manage clinical documents, including clinical plans, protocols, forms, and reports.
- Lead the team in preparing for clinical study initiation, execution, and closeout activities.
- Monitor and report on the progress of clinical studies, addressing issues and coordinating with team members and line managers as needed.
- Communicate and collaborate with cross-functional teams to resolve issues that arise during clinical studies.
- Ensure consistency in clinical study processes across multiple trials.
- Travel as necessary to facilitate program activities and support clinical trials.
Qualifications
- Post-secondary degree or diploma in Life Sciences, Biochemistry/Chemistry, Nursing, or a related field.
- Minimum of 5 years of experience in managing clinical studies or equivalent product development programs. Experience in in vitro diagnostic/medical device studies is an asset.
- In-depth knowledge of Good Clinical Practice and regulations governing in vitro diagnostics/medical devices.
- Advanced skills in project planning and management, with strong judgment, decision-making, and problem-solving abilities.
- Familiarity with new product development methodologies is advantageous.
- Demonstrated creativity in achieving objectives while ensuring compliance with regulatory requirements and organizational policies.
If interested to Apply! Please contact me at
ahmed@intellectt.com or 7326539472