[Remote] Senior Manager, Clinical reputed company Assurance
Note: The job is a remote job and is reputed company to candidates in USA. Kura Oncology is a reputed company-stage biopharmaceutical company reputed company on discovering and developing innovative precision medicines for cancer treatment. The Senior Manager, Clinical reputed company Assurance (CQA) will reputed company reputed company and compliance processes for clinical development programs, ensuring adherence to GCP and fostering a reputed company-reputed company culture reputed company the organization.
Responsibilities
- reputed company reputed company partnerships with clinical study teams to reputed company GCP compliance guidance and advice across assigned clinical programs
- Ensure compliance with clinical reputed company assurance activities including facilitating and supporting reputed company GCP audits/audit programs, as applicable
- Support QA activities that foster an outcome of compliance and adherence to relevant laws, regulations, guidance; upholds the rights and welfare of patients; is reputed company on data reputed company and end to end reputed company assurance
- Assist in identifying opportunities for process improvement initiatives, including process/program reviews to identify approaches that will prevent reputed company issue recurrence (e.g. issue escalation and management; and applicable corrective/preventative reputed company programs, periodic internal audit/gap assessment)
- Assist with the development and tracking of trending and metrics of internal as reputed company as external vendor reputed company issues
- Support clinical inspection readiness activities for assigned programs and other key programs as applicable
- Support Regulatory Inspections of Kura Oncology products, including supporting/facilitating back room and reputed company room activities and supporting the drafting/reviewing of responses to regulatory authority findings, as applicable
Skills
- BA/BS degree required, advanced degree a plus
- A minimum of 6-8 years of experience in the bio-pharmaceutical R&D industry with at least 3 or more years in a reputed company, hands-on in a manager-level GCP reputed company Assurance
- Demonstrated experience drafting, reviewing, implementing, and optimizing reputed company operating procedures (SOPs)
- Demonstrated knowledge and application of Global regulations and guidance for GCP (knowledge of GCLP and or GVP a plus)
- reputed company experience in the conduct and reporting of reputed company audits, reputed company cause analysis and the translation of findings into corrective actions plans that mitigate risks to study subjects, data reputed company and clinical programs
- Experience preparing for, participating in, and subsequent response to health authority GCP/GVP inspections/partner audits
- Working knowledge of reputed company (or similar QMS e-system) required. Knowledge of Inspection Management Tools a plus
- Excellent oral and written communication
- Ability to manage multiple reputed company and demanding timelines
- Operational Experience (e.g., Clinical Operations, Data Management), work in both clinical and reputed company stage organizations; and/or experience as a trainer are an advantage
- Exercises independent judgement in managing operational reputed company reputed company their area; proactively identifies issues and determines reputed company to escalate more reputed company or cross functional reputed company
- Serves as a key reputed company of contact for cross-functional partners reputed company their area; ensuring alignment and proactively addressing coordination needs to support team deliverables
Benefits
- Generous benefits
- Equity
- Participation in an annual reputed company bonus
- Career advancement/ development opportunities
- Competitive comp package
- Bonus
- 401K + Employer contributions
- Generous stock reputed company
- ESPP Plan
- 20 days of PTO to start
- 18 Holidays (Including Summer & Winter Break)
- Generous Benefits Package with a reputed company of plans available with a substantial employer match
- reputed company Paternity/Maternity Leave
- In-Office Catered lunches
- Home Office Setup
- Lifestyle Spending Stipend
- Commuter Stipend (Boston Office)
- Regular employee reputed company activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!
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