Kitchen manager in állások, munkák klinikai kutató kategóriában

Working independently in the areas of valve crimping, case management, pre-case planning, post-case management, 3 Mensio management, Therapy Awareness program management and clinical education programs...

• Accountability to lead teams within overall CMC development project(s)
• Drive strategies and activity within the team to support overall development plan.
• Establish good working relationships with internal and external stakeholders

• Responsible for the quality control of clinical trials phase I to IV, both nationally and internationally
• Ensure study sites conduct clinical trials in accordance with the protocol, ICH-GCP guidelines, and the applicable regulations

• Responsible for performing laboratory-based activities and processes
• Tracking, inventory, sample processing, and transport of biological samples from clinical and non-clinical trials
• Manage associated metadata, and ensuring that lab activities fulfill customer needs

In your new role, you will define and implement the global strategy for analytical development, supporting BI's pipeline from early research through candidate characterization and selection to drug product development and launch....

Deliver technical expertise in the development of container closure systems, including vials, prefilled syringes, and prefilled cartridges, by employing cutting-edge methodologies to conduct comprehensive analyses and evaluations of their protection, safety, compatibility, and performance attributes...

• Act as the clinical leader and primary clinical representative for global programs, ensuring high quality and speed of functional deliverables.
• Develop a clinical vision for addressing unmet medical needs, considering the molecule's scientific hypothesis.

• Overall medical and clinical strategy leadership for late-stage (Phase 2/3 and Phase 3 pivotal) development programs
• Medical leadership of clinical trial design and execution, including diagnostic and therapeutic radiopharmaceutical studies

Lead technical investigations for customer complaints and product CAPAs assigned to R&D, evaluate technical issues that occur during daily use of our systems in hospitals and act as key reference within the R&D team...

• Collaborating with technical experts in the development and enhancement of sensors for blood gas analysis.
• Contributing to sensor design investigations by planning and conducting various material and sensor characterization experiments and tests.

• Oversee work for timely completion of a complaint investigation and response to the various customers
• Communicate with customers regarding complaints, product issues and returned devices

• Batch record review for API and bulk product for monoclonal antibody prefilled syringes
• Assessment and documentation of product deviations, OOS, and changes
• Quality oversight for relevant service providers, including CMO's, laboratories, technical operations and supply chain