Manager Clinical Quality Management
Manager Clinical Quality Management
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Job Description
The Manager Clinical Quality Management is responsible for managing local SOP TMF plan relevant systems/process for clinical operation Quality oversight of clinical trial supporting for planning and conducting global annual audit plans and all activities to maximize clinical operation capability across studies for Japan.
He/She collaborates with multiple functions in Quantitative Sciences and Development Operations (QSDO) and R&D Quality & Compliance (RDQC) to be consistent with global process and also work within and outside R&D such as global/local finance or sourcing team.
He/She serves as the leader of the Japanese inspection response team responsible for preparing for and responding to inspection conducted by PMDA. Also he/she acts as the primary point of contact for the global inspection team and regulatory authorities leading the coordination of inspection responses.
As part of vendor management responsibilities he/she collaborates with stakeholders both within and outside the R&D department such as Japan Study Lead (JSL) Clinical Financial Planner (CFP) Global/Local finance and sourcing teams to be responsible for budget management and contract management processes of local CROs and vendors.
Clinical Quality ManagementLocal SOPTMF/
GlobalQuantitative Sciences and Development OperationsQSDOR&D Quality & ComplianceRDQC
PMDAGCP
Vendor managementCROvendorJapan Study LeadJSLClinical Financial PlannerCFPGlobal/LocalR&D
Qualifications :
- Total 10 year experience in clinical development field and 5 year experience of managing clinical trial activities or GCP compliance.
- Need global study experience Quality control including maintenance of CTMS TMF or SOP.
- Thorough understanding of GCP regulations guidelines and industry trends.
- Businesslevel English to collaborate effectively with the global team.
- Science background and education (Bachelors Degree or equivalent)
- 10GCP5
- CTMSTMFSOP
- GCP
Additional Information :
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a midsized biotechnology company we provide the stability and resources of a wellestablished business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver lifechanging medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
