Clinical Affairs leadership positon within Abbott Diagnostics Hematology business unit. Responsible for global clinical studies for Hematology IVD products. Lead resources within Hematology and partner clinical sites globally to achieve clinical objectives. Lead a team of approximately 4 in clinical affairs. Reports to the Director, Clinical Affairs for Hematology.
The Manager has business unit-wide influence, responsibility and functions as an internal expert resource. The individual will be actively called upon to provide clinical affairs guidance to business unit leadership and project teams. In addition, this role is responsible to:
Responsible for implementing and maintaining the effectiveness of the quality system.
Responsible for executing the following:
- Manage staff (i.e. clinical operations specialists) to ensure efficient execution of clinical research activities
- Manage clinical operations activities in support of clinical study timelines and in accordance with applicable regulations; GCP; and ADD policies and procedures.
- Supports clinical research team with review and monitoring of clinical study data as needed.
Manage development and tracking of Clinical Research Process Metrics to facilitate continuous improvement.
- Manage tracking and reporting of Clinical Research activities for Sunshine Act reporting.
- Provide leadership; direction and accountability for clinical research process improvement projects.
- Verify that changes related to process improvements have been established through objective evidence review of metrics; documents or other clinical research related data.
- Provide leadership; direction and accountability for new technology projects for the Clinical Research organization.
- Provide input into the strategic plan and long range plan for the Clinical Affairs organization; as needed.
- Effectively communicate; through the planning and execution of meetings and presentations; project goals; milestones and updates; to senior management and other functional areas; and regulatory authorities.
- Maintain a professional; product; and market expertise via independent reading; networking and training.
- Interview job candidates and hire staff. Manage the orientation and training for new staff members. Prepare and conduct performance evaluations.
- Actively participate in establishing best practices through strategic planning; training and writing/editing appropriate documentation.
- Manage department expenses within budget.
Accountable for achievement of both financial and performance goals for projects and overall area of responsibility. Responsible for mentoring direct reports and providing guidance with their career development. Remove barriers impeding the progress of projects and programs. Recommend actions and develop responses to cope with changing requirements and regulations. Anticipate future direction and participate in conflict resolution at the management level.