Position Accountability/Scope:
Develop study management plans, together with team assignments and accountabilities and oversight of database and study maintenance.
To provide appropriate information for local and central tracking systems within required timelines
Serve as primary project contact with vendors to ensure communication is maintained and reporting and tracking schedules are adhered to through study execution phase.
Manage and co-ordinate with cross-functional project teams to support milestone achievement and to manage study issues and obstacles and ensure compliance with standard processes, policies and procedures.
Maintain appropriate communication with relevant functional areas
To anticipate and proactively solves study-related clinical site issues as they occur and initiates, recommends and communicates corrective action as indicated. Use functional expertise and exercise good judgment in seeking appropriate guidance and ensure that follow-up to any and all corrective action is taken at the clinical site and is properly documented
Undergo and maintain training as required by the functional role and other relevant company procedures, to ensure adherence to ICH-GCP, Abbott SOPs, processes and procedures, local Work Instructions (if any), applicable regulatory requirements and study specific needs
Provide input for the development of clinical study proposals and study documents for clinical studies and manage project within approved budgets.
Contribute to achieving satisfactory study audits internal and external.
Forecasting budget for assigned studies and keeping a track on planned actual expenditure for assigned studies to ensure the study budgets are on track
Vendor identification, management, operational and finance tracking
Clinical Supply Management
Maintain at most quality for study related documents and all the clinical trial activities performed
Forecasting study milestones of assigned clinical trials and accomplishing deliverables as per the planned milestones
Mentoring juniors and interns (if any) at Abbott for activities related to clinical research
Ensure together with line manager appropriate delegation of study related responsibilities during absence.
Ensure safety reporting requirements and reviews of the documents as per PV SOPs and process.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
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