A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Central Monitoring Ops Manager
Job Description
1. Work closely with the Group Head, CCReM on trial allocation to cCRAs and cCRA resource utilization
2. Support Group Head in the hiring, training, mentoring and supervising cCRAs. Manage and direct team members with problem solving at the trial/country level where needed.
3. Identify skills and competency gaps. Work with training team to develop training plans and coordinate training as needed.
4. Provide common understanding to Clinical trial teams (CTTs) of the competitive environment in clinical trial conduct while leading the development and implementation of Central Monitoring Strategy.
5. Have an oversight on the team performing ongoing central remote monitoring of patient data using available online data sources (eCRF, IRT, central lab etc.) and remote monitoring tools like CAF and Spotfire to ensure consistency and correctness of the data.
6. Communicate any observations: deviations to protocol, safety alerts, quality issues, entry patterns, risk factors etc. that may affect the planned conduct of the trial to the clinical team and local ICRO organization for timely follow-up actions and issue resolution.
7. Support Group Head in the review of the status of planned versus actual patient recruitment and support the implementation of strategies to correct deviations from proposed plans according to metrics.
8. Work with GTL / DM / ICRO Managers to identify potential quality issues and implement actions to resolve them
9. Provide liaison interface with other global line functions.
10. Provide Lead in the development of Central Monitoring Documents and other related documents, in the ongoing scientific review of clinical data, and in trial data analysis and reporting. Support Group Head in preparing training materials and presentations. Acts as a close partner with the local ICRO CRAs, CSMs and Global Trial Lead. An ad hoc team member of the clinical trial team (CTT), as and when required
11. Interact with DM / CAF/ programming group and/or other line functions to ensure that efficient tracking and data reports are generated as required with flags and alerts for relevant deviations and queries in the database. Have oversight for accuracy of trial information in all trial databases and tracking systems.
12. As applicable support Group Head for ongoing medical/scientific review, and ongoing clarification of all remote queries to ensure smooth clinical database locks.
13. Lead and participate in multi-disciplinary teams within GCO and with different line functions to evaluate and implement central monitoring process improvement.
Candidate Profile
Life Science Post Graduate, Pharma, Medical or Nursing degree or equivalent. Fluent English (oral and written).
1. At least 5 years experience in clinical development/project management, including involvement in cross-functional, multicultural and international clinical trial teams; demonstrated capabilities in leading specific trial related activities like planning, executing, reporting and publishing activities.
2. Excellent communication, organization and tracking skills. Strong operational skills and demonstrated ability to meet timelines.
3. Proven ability to work both independently or in a team setting, including a matrix environment
4. Knowledge of Good Clinical Practice; thorough knowledge of clinical trial design; understanding of the overall drug development process.
5. Good leadership, negotiation and project management skills
6. Robust knowledge of the regulatory and local requirements within regions and countries
7. Medical / Scientific knowledge of the assigned therapy area and associated trial designs
8. Demonstrated presentation and diplomacy skills
9. Willingness to act accountably in project / trial management
Additional Information:
Job ID: 155446BR
Experience: Min. 5 Year
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: CR
Location: Hyderabad
End Date: 30th Jan, 2015
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