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- Determines NTA or applicable project objectives, strategy, scope and schedule to meet business needs. Develops the NTA or applicable project Plan in consultation with the cross-functional project team, project stakeholders and the clinical team. Presents project plans, provides ongoing updates, and presents project results to Division senior clinical management.
- Assists in the management and execution of the NTA and/ or applicable clinical project.
- Ensures all Division staff are trained on the requirements of the clinical project and project plan.
- Responsible for ensuring the clinical project is "audit ready" at all times (project team training records, central files, system validation, etc.).
- If applicable, ensures adequate monitoring is conducted on all clinical project, conduct clinical visits as needed to support NTA and/ or applicable clinical project.
- Provides oversight of NTA and clinical projects to ensure safety concerns and/or adverse events or trends in Field Events Reporting are identified and appropriate responses are developed and executed.
- Provides clinical input and support for planning post-project activities and product market launch.
- If applicable, authors/co-authors project results in medical literature plans and/or presents at scientific investigation meetings.
- Controls device distribution and allocation.
- Monitors project reports for accuracy and trending, provides input to project budgets and project plans and clinical scientific support to project teams.
- Evaluates clinical data in preparation of study summary reports for presentations, publications, and submissions.
- Develops and implements corrective actions as needed to address any noncompliance issues.
- Performs LA Reviews of marketing materials related to NTA or applicable clinical project.
- Provides input and support for planning post-trial clinical activities and product market launch.
- Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
- Bachelors Degree Engineering, biological sciences or related medical/scientific field. Preferred Masters Degree or Doctorate Degree.
- Minimum 3 years experience directly supporting clinical research or similar experience in a medical/scientific area, plus 1-3 years experience managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development setting.
- Proficient knowledge of medical terminology. Expertise with GCPs, and regulatory compliance guidelines for clinical trials (e.g. applicable ISO Standards, FDA). Strong problem-solving skills.
- Advanced knowledge of clinical and outcomes research study design. Strong computer skills. Demonstrated ability to work effectively on cross-functional teams.
- Experience with software related testing and validation are preferred.
Clinical Project Manager - Alameda, United States - Abbott
Description
The Opportunity
The Clinical Manager is responsible for managing and meeting the objectives of clinical projects including but not limited to New Technology Assessments (NTA). Internally interfaces with data management, biostatistics, regulatory, clinical research associates, trial coordinators, field clinical specialists, functional management, cross-functional team members and business alliance leads (sales and marketing).
What You'll Work On
Required Qualifications