PerkinElmer is now looking for
We are looking for a dynamic clinical operations leader with extensive experience in IVD clinical trials to join the global Medical and Scientific Affairs team at PerkinElmer. The Medical and Scientific affairs team provides leadership in clinical and medical strategy, as well as operation excellence in clinical studies to support launch and promotion of PerkinElmer Diagnostics products for various disease areas using proteomic, molecular and genomic technologies.
(1) In accordance with the business objectives,
- provide strategic planning of required clinical activities to support registration of new or changed products, business development and enable research and development globally for reagents, instruments and software.
- direct planning and implementation of all activities required to conduct and monitor clinical studies ensuring adherence with Good Clinical Practices (GCP) and local regulatory requirements.
- make decisions on the recruitment/selection of investigators and contract research organizations (ie scope of work development, bid review, negotiations and oversight).
(2) Responsible for,
- subject matter expertise in disease areas, ICH and local regulatory requirements, and clinical operation activities.
- preparation and providing clinical deliverables for registrations.
- daily management and the professional development all clinical personnel.
- tracking of clinical expenses for reporting to finance
- the tracking and reporting of clinical expense and department expense to manager on monthly basis.
- providing monthly updates on status of clinical activities with analysis of timelines and cost by actual versus planned.
- overseeing all clinical study activities and assuring quality in all such as implementing new or updating existing SOPs, budget preparation, timeline preparation, coordination with other functions (regulatory, business, operations) to assure transparency and coordination in studies.
- Conducting productive communications to management, external customers (investigators, ethical committees, etc) and internal customers (inter- and intra department) concerning clinical activities.
- Providing solution-oriented service to internal and external customers
3) Occupational and environmental safety
- Responsible for implementing the current environmental program and control of environmental friendly practices in his/her department.
- Responsible for occupational safety, working instructions and training taking into account occupational safety, as well as the safety of work equipment in his/her department.
- Guidelines and monitors the use of protective equipment.
What we offer: