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发表于 2012-10-12 14:51:10
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Post MMDP Assignment
• A new job is assigned from the 3rd year in a way to best balance individual goals and business needs of the division.
• Periodical employee development plans following MSD career maps
• Work Location: Hangzhou, Shanghai
MMDP Candidates Requirements
• Bachelor's/master's degree, graduating in 2013 (major: Engineering, Pharmacy, Chemical Engineering)
• Fluent English (minimum: CET-6)
• Outstanding academic records of achievement and demonstrated leadership abilities;
• Individuals who are analytical and inquisitive about the interrelationships of various components;
• Quick learners committed to making a difference in the pursuit of manufacturing high-quality, market-leading products.
北京研发中心职位（15名）：
Associate Data Coordinator-PV
Primary Activities:
His/Her tasks depend on the Process/role assigned: Registry and Case Processing, Junior PV Lead, Reviewer.
• Perform registry and case assignment tasks as needed.
• Perform data entry/review of all adverse experience information received and processed within internal database within the established timeframes.
• Through daily case prioritization activities, reports are completed within the established timeframes to ensure compliance with internal, business partner, and regulatory agency reporting requirements worldwide.
• Participate/perform in training and certification activities for PV GDMS.
Other activities that the Coordinator can be assuming depending of the role: PV lead
• Provide franchise team support by ensuring the appropriate resources such as SOPs and product/protocol guidelines are available and routinely updated to ensure the quality of reports.
• Oversee redistribution of workload within franchise and across franchise with manager support to ensure reporting timelines are met.
• Assist management to ensure key performance indicator targets are met. Assist with root cause analysis and oversee implementation of actions plans when appropriate.
• Identify coordinator, team, franchise, training and/or processes related issues and escalate to PV liaison, PV trainer or DMC PV management as appropriate.
• Actively participate and ensure effective communication with different roles in Global Safety, DMCs and other areas.
Reviewer
Perform case review of adverse experience information within the established timeframes to be compliant with internal, business partner, and regulatory agency reporting requirements worldwide.
Assist managers with reviewing individual coordinator report quality.
Requirements:
A bachelor's degree, preferably in a medicine, pharmacy, nursing or biological science
Excellent organizational, workload prioritization and time management skills
Excellent overall communication skills with advanced oral and written English skills
Advanced computer skills
Independent, strong analytical and problem solving skills
Good sense and awareness of regulations and policies
Able to work under the pressure, strong sense of responsibility and accountability
Associate Data Coordinator-CT
Primary activities:
His/Her tasks depend on the Process/Role Assigned: Data Enterer, Data Reviewer, Manual Encoder, and Data Project Lead (DPL).
Data Enterer
• Performs Sponsor Data Entry as applicable per protocol-specific Data Management Plan (DMP) following protocol-specific eCRF Entry Guidelines.
Data Reviewer
• Runs data integrity check reports in accordance with protocol-specific Data Review Plan (DRP) to identify data missing, inconsistencies or departures from protocol-specific eCRF Entry Guidelines.
• Raises queries with investigational site staff and reviews responses and corresponding data corrections to confirm identified issue resolution.
• Escalates overdue items including but not limited to outstanding queries and missing visits and reports the outstanding items resolution status to the DPL.
• Assists the DPL with data management activities to ensure all identified data issues are resolved and data are clean prior to study database lock.
Manual Encoder
• Encodes medical terminologies as applicable per protocol-specific DMP and Global Encoding Practices Document.
• Runs encoding check reports in accordance with protocol-specific data review plan to identify encoding issues including but not limited to unspecified encoded terms, encoded term inconsistencies or departures from protocol-specific eCRF Entry Guidelines.
• Raises query with investigational site staff and reviews responses and corresponding data corrections to confirm resolution.
DPL is the Lead Data Reviewer for a protocol within a Data Management Center (DMC). His/her responsibilities include but not are not limited to:
• Ensure compliance of standard key performance indicators according to process expectations at protocol level.
• Monitors data quality and cycle-time performance measures to ensure compliance and perform root cause analysis and implement action plan as needed.
• Coordinates and mentors data reviewers who work in his/ her protocol to ensure their compliance with SOPs, protocol-specific DMP and DRP.
• Communicates with sites and country Clinical Research Associates to ensure timely resolution of data issues and overdue items including but not limited to outstanding queries and missing visits.
• Works with the global study DPL team to provide protocol data management progress update at DMC level and discuss identified scientific and technical issues for resolution.
• Proactively communicates with DMC management to share project status, risk assessment and outstanding item resolution status.
Requirements:
Education:
At least B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline
Knowledge and Skills:
Self-motivated, excellent in work planning and time management
Fluent oral and written English skills
Good sense and awareness of regulations and policies
Able to work under pressure and change environment with flexibility
Good communication skills with the ability to communicate with both the technical and business areas.
Biostatistics
The Department of Biostatistics and Research Decision Sciences (BARDS) is a key functional group in the Merck Research Laboratories (MRL), Merck & Co, Inc. This department provides statistical support in the design and execution of Merck's non/pre-clinical and clinical development programs.
BARDS has 1 position in Early Development Statistics for a full-time student in China who is pursuing a MS or PhD degree in Statistics, Biostatistics, or Epidemiology. You will work closely with experienced pharmaceutical industry statisticians to perform applied statistical research and/or statistical analysis of data related to drug discovery and development.
Qualifications:
Full-time students in China who
Completed at least 2 semesters of graduate work towards a MS or PhD degree in Statistics, Biostatistics, or Epidemiology by July, 2013
Have effective oral and written communication skills in English
Have a good working knowledge of R
Scientific Programmer
Scientific Programming (SP) is an important group within the Department of Biostatistics and Research Decision Sciences (BARDS) of Merck & Co, Inc. It collaborates closely with different functional areas to provide statistical programming support on clinical trial data analysis and reporting.
The group has a few positions for a full-time student in China currently pursuing a MS or PhD degree in Statistics, Biostatistics, Computer Science, or Computer Engineering. This position will be in the BARDS's Asia Pacific hub, located in the Merck Research Laboratories (MRL) Asia R&D Center, Beijing Wangjing area. You will work closely with experienced pharmaceutical industry statisticians and programmers to support the statistical analysis of clinical trials for drug and vaccine development.
Qualifications:
Full-time students in China who
Completed at least 4 semesters of graduate work towards a MS or PhD degree in Statistics, Biostatistics, Computer Science or Computer Engineering by July, 2013;
May get the degree in the aforementioned disciplines by July 2013
Have effective oral and written communication skills in English;
Have a good working knowledge of SAS, Microsoft Word and Microsoft Excel.
Late Development Statistics
The Department of Biostatistics and Research Decision Sciences (BARDS) is a key functional group in the Merck Research Laboratories (MRL), Merck & Co, Inc. This department provides statistical support in the design and execution of Merck's clinical development programs.
BARDS has a few positions in Late Development Statistics (LDS) area for a full-time student in China who is pursuing a MS or PhD degree in Statistics, Biostatistics, or Epidemiology. This position will be in BARDS's Asia Pacific hub, located in the MRL's Asia R&D Center, Beijing Wangjing area. You will work closely with experienced pharmaceutical industry statisticians to perform applied statistical research and/or statistical analysis of data related to drug and vaccine development.
Qualifications:
Full-time students in China who
Completed at least 4 semesters of graduate work towards a MS or PhD degree in Statistics, Biostatistics, or Epidemiology by July, 2013
May get the degree in the aforementioned disciplines by July 2013
Have effective oral and written communication skills in English
Have a good working knowledge of SAS, S-Plus, and/or R
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发表于 2012-10-12 14:44:45
