3 days old

Country Study Manager

上海, Shanghai
Country Study Manager
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Collarboration and Communication
Key contact person for CRAs, regional and global team in assigned study
Develop and maintain relationships with prioritized institutions and investigators within a specific TA and in assigned studies
Facilitates investigator site communications (e.g., newsletter, enrollment updates)
Support TA COM on strategic site development and partnerships
Propose innovative solutions to optimize processes

Business Deliverables
Accountable for study timeline, quality and budget plan and delivery at country level
Provide operational strategic input to early protocol development and study timelines
Lead Country level feasibility
Lead CRA team to identify, screen, evaluate and select sites partnering with quality team to ensure site qualification for a specific study participation
Coordinate and facilitate study training planning and implementation
Responsible for country level site activation process, timeline, risk management, contract budget approval & control
Actively coordinates, participates and presents in AST, ISST and/or SIVs as required
Provide input into study related vendors selection, such as vendors for quick start up, recruitment, etc., review and approve vendor payments, oversight vendor deliveries
Coordinate and facilitate enrollment readiness including all local set-up activitiesCFDA study information online registration and HGRAO submission in preparation for FPV
Lead CRAs to develop enrollment plans ensuring appropriate risk/mitigation at each site in order to meet targets
Provide input and/or develop and maintain country level monitoring plans as required
Oversights monitoring intervals, SDV/SDR backlog and site compliances
Monitoring oversight including sampling review monitoring visit reports, meetings with Study Report Reviewer Specialist and COM
Oversight site-level data entry and query resolution
Co-ordinate and conduct study based co-monitoring with CRAs as required
Accountable for country level Issue Management and Protocol deviation review
Oversight of study timeline, SDV status and data query resolution as planned
Verify and approve site payment
Lead and ensure site self check process within planned time
Ensure timely closeout site summary and CSR stamping
Create and maintain Country level system such as eTMF and sCTMS with completeness and high quality
Oversee site level TMFs to ensure completeness, accuracy and updated in a timely manner
Collaborate in the preparation of local quality/compliance reviews, internal audits and regulatory inspections and ensures adequate and timely CAPA follow up
Identify quality issues within the study to implement appropriate corrective action plans or escalate to appropriate level for resolution

Regulations and Compliance
Responsible for understanding and complying with all regulatory requirements, ICH/GCP guidelines
Responsibilities include understanding and following all compliance, procurement, legal, financial and Global Medical Standards and Procedures
Coordinate internal process of Anit-Corruption Due Diligence (ACDD) with inverstigators
Resposible for site-level audit and inspection activities from clinical operation perspective
Maintains familiarity with regulations and guidelines regarding study execution practices 53943BR
Minimum Qualification Requirements:
At least Bachelors degree or equivalent work experience in a scientific or health-related field
Minimum of 3-5 years CRA or 2 years country study manger or similar position working experience in Clinical Trials
Fluent English communication in reading, writing and spoken formats
Strong self-management and organization skills
Project management skills
Strong problem solving and communication skills (both verbal and written)
Good computer Microsoft office software skills
Need to travel periodically to ISST, comonitoring activities and potentially other scientific/regional meetings
Need to have frequent meetings with global team out of working time.
Other Information/Additional Preferences:
Strong analytical skills
Proficiency in use of project management tools such as Excel, MS project, risk assessment and contingency planning
Strong leadership and networking skills
Strategic thinking
Self-motivated and with good teamwork spirit
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  • Science
Posted: 2019-12-03 Expires: 2020-01-02

As one of the oldest continuously operating companies in the United States, we are proud of all the innovative work we’ve accomplished for the last 140 years to improve global health.

We are looking forward to an even more successful future in which continued innovation and contributions from top talent in all areas of our organization will be critical.

Are you looking for a way to make life better for people around the world? We have opportunities in many areas of our organization. Please use the search feature to see the wide scope of our positions.

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Country Study Manager

上海, Shanghai
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