Operations Manager-Clinical Research Allied Services Jobs in Aundh on your local Aundh jobs site. Careers in Aundh, local employment and work in Aundh.
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Operations Manager-Clinical Research Allied Services
This job has expired, and cannot be applied for.
- Posted By: GR Placements, Pune
- Address:
- Date Posted: 8th Feb 2010
- Salary: Negotiable
- Location: Aundh (411001)
- Reference Code:
- Views Since Posting: 268
- Full Description:
Operational Manager-Clinical Research Allied Services
The expertise of the profile should be in Data Management / Pharmacovigilance/CDISC primarily and might involve travel to US / UK on business need basis but initially first few years would be to look after Indian operations.
Data Management
•Involves initially for 6 months with training initiatives both for internal and external customers on Data Management (paper / hybrid / EDC) subsequently will be involved extensively on domestic/international projects.
•Responsible for internal & external training of the fresh resources based on the business requirement.
•Manage the allocation of Data entry and data validation staff for upcoming projects.
•Provide regular status reports to Senior Management.
•Provide input into development of new systems and processes, as required.
•Liaise with facilities management to ensure desk and office space are allocated appropriately to all projects & Training.
•Liaise with IT department to ensure hardware requirements are in place for all existing and new staff.
•Support with the Corporate Training requirements to ensure the training needs of all Data Management staff are identified and addressed on an ongoing basis, including training on new systems and applications
•Spend up to 50% of their time training Data Mgt staff on Data Management processes and new technologies.
•Support the establishment of training programs (technical and professional skills) for internal & external resources training is conducted and properly documented.
•Select, recruit, develop, manage, motivate, coach and appraise the performance of direct reports and ensure high quality performance management across Data Management Group. Contribute to the development of the Data Management organization through his/her global leadership role on the management team.
•Represent Data Management & Pharmacovigilance as well as other EDM partners at the operations meetings and provide timely feedback to partners.
Pharmacovigilance
•Involves initially for 6 months with training initiatives both for internal and external customers on Pharmacovigilance (Argus / Aris-G /AERS) subsequently will be involved extensively on domestic/international projects.
•Experience in Pharmacovigilance with hands on experience on Oracle-Argus.
•Responsible for internal & external training of the fresh resources based on the business requirement.
•Experience in case processing, Data Entry, Case Review.
•Safety & Risk Mgmt section of the clinical trials
•Knowledge in preparing and submitting the CIOMS, Medwatch, PSUR, risk management plan, Literature review, Signal Detection,PSUR
•Safety Analysis Plan, Risk management analysis
•Managing workload and allocating resources based on the requirement.
•Lead, coordinate or support data management initiatives as and when needed.
CDISC
•Standardization of CDMS (paper / EDC / Hybrid / Indigenous) tool according to CDISC standards by creating CDASH variables across all domains.
•Good understand of CDISC standards for data management activities.
•Should able to develop a plan for legacy data, new trail data, just completed trail data and upcoming trail data according to CDISC standards both for the paper / EDC trail .
The expertise of the profile should be in Data Management / Pharmacovigilance/CDISC primarily and might involve travel to US / UK on business need basis but initially first few years would be to look after Indian operations.
Data Management
•Involves initially for 6 months with training initiatives both for internal and external customers on Data Management (paper / hybrid / EDC) subsequently will be involved extensively on domestic/international projects.
•Responsible for internal & external training of the fresh resources based on the business requirement.
•Manage the allocation of Data entry and data validation staff for upcoming projects.
•Provide regular status reports to Senior Management.
•Provide input into development of new systems and processes, as required.
•Liaise with facilities management to ensure desk and office space are allocated appropriately to all projects & Training.
•Liaise with IT department to ensure hardware requirements are in place for all existing and new staff.
•Support with the Corporate Training requirements to ensure the training needs of all Data Management staff are identified and addressed on an ongoing basis, including training on new systems and applications
•Spend up to 50% of their time training Data Mgt staff on Data Management processes and new technologies.
•Support the establishment of training programs (technical and professional skills) for internal & external resources training is conducted and properly documented.
•Select, recruit, develop, manage, motivate, coach and appraise the performance of direct reports and ensure high quality performance management across Data Management Group. Contribute to the development of the Data Management organization through his/her global leadership role on the management team.
•Represent Data Management & Pharmacovigilance as well as other EDM partners at the operations meetings and provide timely feedback to partners.
Pharmacovigilance
•Involves initially for 6 months with training initiatives both for internal and external customers on Pharmacovigilance (Argus / Aris-G /AERS) subsequently will be involved extensively on domestic/international projects.
•Experience in Pharmacovigilance with hands on experience on Oracle-Argus.
•Responsible for internal & external training of the fresh resources based on the business requirement.
•Experience in case processing, Data Entry, Case Review.
•Safety & Risk Mgmt section of the clinical trials
•Knowledge in preparing and submitting the CIOMS, Medwatch, PSUR, risk management plan, Literature review, Signal Detection,PSUR
•Safety Analysis Plan, Risk management analysis
•Managing workload and allocating resources based on the requirement.
•Lead, coordinate or support data management initiatives as and when needed.
CDISC
•Standardization of CDMS (paper / EDC / Hybrid / Indigenous) tool according to CDISC standards by creating CDASH variables across all domains.
•Good understand of CDISC standards for data management activities.
•Should able to develop a plan for legacy data, new trail data, just completed trail data and upcoming trail data according to CDISC standards both for the paper / EDC trail .
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