Site Name: India - Karnataka - Bengaluru
Posted Date: Mar 16 2021
Are you energized by the opportunity to partner with key leaders in global medical science to enhance global operational support? If so, this Clinical Study Management Manager could be an exciting opportunity to explore.
As a Clinical Study Management Manager, you will provide operational support to the Global Medical Sciences team within the business and provide flexible operational support within various functions across Global Medical Sciences.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...
- Lead the India Study Delivery Team to execute VEO studies with high quality to schedule and budget. Serve as escalation point for the Study Delivery Lead (SDL) to raise and assist with study execution issues and risks
- Lead SDL team to deliver VEO studies within TA - Carefully weigh the priority of activities and direct team accordingly
- Plan, allocate, review and organize staff assignments. Provide leadership, coaching, guidance as well as training and staff development opportunities. Responsible for hiring and performance management process.
- Lead study execution, tracking and management of assigned studies - The Sr. SDL is the operational team leader for VEO sponsored research study teams with overall accountability to the VEO scientist for study implementation and end to end study operational excellence from concept to publication/submission.
- Coordination of full feasible Study Protocol
- Ensure timely delivery of study documents.
- Lead vendor selection and contractual agreements
- Lead escalation and resolution of operational issues
- Work directly with VEO scientists to ensure effective planning and ensuring all studies conducted comply with GSK SOPs.
- Manage, in collaboration with Study Delivery Associates (SDA) and Procurement, RFP, proposal, purchase order requesting and contract execution aspects of the activities and liaise with vendors
- Ensure activities are registered correctly in GSK enterprise systems, in collaboration with central business groups supporting those systems and processes and with other members of VEO Business Operations
- Manage, in collaboration with SDAs and other members of VEO, end to end documentation needs and processes for the activities
- Prepare for audit of VEO activities
- Ensure that VEO activities remain compliant with relevant GSK procedures, remaining up to date with all relevant training and seeking learnings and best practice from other GSK teams and external organisations, to develop best practice and innovation in study operations
- Maintain regular interaction with all study team members to ensure issues / risks / successes with study delivery are reviewed and/or shared as they occur.
- Drive innovative approaches to study delivery through external facing advances in technology and sciences
- Supporting technical and leadership development of Study Delivery staff via mentoring and coaching.
- Advanced scientific or business degree or equivalent experience
- Experience in health outcomes research, patient reported outcomes, or epidemiology.
- Proven track record of leading a clinical matrix team and working with investigators, external experts, Contract Research Organizations, Local Operating Companies, and vendors
- Leadership and line management skills/experience
- Demonstrated hands-on clinical operations experience preferably across a range of therapeutic areas and/or study types
- Experience in developing and contributing to study protocols, study procedure manuals, informed consent forms, clinical study report, and manuscripts
- Experience of vendor oversight and relationship management etc
- Knowledge of the principles of quality, safety, risk management and compliance (ICH and GCP
- Demonstrated ability to create and foster strong strategic partnerships with colleagues that include Clinical Development, Global Regulatory Affairs, Clinical Pharmacology, Statistics, Medical Affairs, Data Management, Study Monitoring
- Ability to work independently and proactively
- Proven track record of applying operational knowledge to identify and analyze problems and information of considerable complexity and implement effective plans and solutions.
- Excellent communication skills including verbal and written communications, with the ability to present to internal department meetings and external advisory/investigator meetings.
- Ability to prioritize effectively and meet multiple deadlines successfully with attention to detail, setting high performance standards.
- Flexibility and willingness to take champion new approaches
- Excellent interpersonal skills
- A collaborative and partnering style.
- Good organizational and time planning skills
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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