Clinical Serology Project Manager
Clinical Serology Project Manager
Apply NowJob ID1601199Date posted10/20/2016LocationZurich, Switzerland;
Contribute to the success of a serology function assigned to global clinical development programs (e.g. Dengue, Norovirus) within the Vaccines Business Unit (VBU), coordinate and drive the timely delivery of clinical serology assays through collaboration with Analytical Development, and to manage and oversee clinical sample handling and testing with the clinical assays in contracted laboratories. Ensure timely delivery of quality clinical serology data to assess clinical endpoints in clinical studies, in compliance with Takeda processes and international regulatory and quality standards.
- Support global objectives of Clinical Development and Head of Clinical Serology in VBU.
- Manage and oversee timely delivery of clinical serology assays of appropriate quality and to assess clinical endpoints in clinical studies of vaccine development as based on the clinical assay strategy in accordance with regulatory requirements e.g. EMA/FDA guidelines, and quality standards, e.g. Good Laboratory Practice.
- Collaborate with academia, bio-analytical lab vendors and in-house labs for assay development.
- Lead serology approach by establishing the Serology Plan reflecting the serology needs of a clinical study, managing operations thereof and seeking for alignment with the Clinical Trial Team.
- Support drafting and execution of contracts and Work Orders with bio-analytical vendor labs, based on Serology Plans.
- Oversee and manage the serology budget of clinical sample testing for all studies of the program.
- Lead sample management during the whole process of the clinical study. Oversee shipment, management and storage of clinical samples.
- Oversee the review and execution of the Lab Manual for sample management, provided by the contracted vendors. Partner with Clinical Delivery manager to implement the Serology Plan for the clinical endpoints in studies, in compliance with GCP-ICH guidelines.
- Inform Quality Assurance team about a quality deviation of sample management and clinical sample testing.
- Oversee documentation of the above quality deviations in the electronic quality management system.
- Oversee all timelines of clinical assays: from the development and validation of assays to the delivery of QC/QA results of clinical sample testing to Statistic and Data management. Provide regular updates to clinical teams on status and timelines.
- Oversee gapless documentation of any documents in the trial master file (TMF) owned by serology in accordance with regulatory requirements and the Takeda Quality management system.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- MS degree in life sciences with a minimum of 7 years laboratory experience, or PhD in life sciences with a minimum of 5 years laboratory experience.
- At least 5 years working experience in the pharmaceutical industry, preferably in vaccines.
- Experience and demonstrated success in the development and, validation and clinical sample testing by using serology assays and other bio-analytical methods. This includes experience and understanding in working with blood borne pathogens and human serum.
- Background in virology (e.g. flavivirus, alphaviruses, calicivirus) and vaccine development is desirable, as well as in immunology and molecular biology.
- Basic understanding of GMP, GCP-ICH and GCLP guidelines.
- Understanding of the vaccine development process and experience with the support of clinical trial teams.
- Fluent English in speaking and writing.
- Successful experience in working with globally operating matrix teams and in the coordination with various internal and external interfaces (academia, in-house labs and contracted vendors).
- Strong communication, strategic, analyticalproblem-solving& interpersonal skills
- Readiness to travel internationally as required.