Senior Research Manager, US Medical

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Job Description

The objective and purpose of the Senior Manager, US Medical Clinical Research, RPE position is as follows:

• Partner with Director, Research Process Excellence, RPE to support process for US Medical Research studies, including Medical Company Sponsored Studies (MACS), Collaborative Studies and Investigator Initiated and Sponsored Research (IIR) studies for multiple therapeutic areas and product programs. Manage study budgets and communicate study activities to team members.
• Responsible for the process to help conduct MACS, Collaborative and IISR studies as applicable within assigned TA observing all applicable internal legal and compliance policies and external regional and country specific regulatory guidelines.
• Support assigned therapeutic area when working and collaborating with team members (e.g. GMA Region and LOC medical leads, TA Medical Heads, alliance partners, etc) and external investigators to develop US Medical clinical research plans and budgets.

May lead special projects according to US Medical our needs (e.g. external engagement's, process optimizations).

ACCOUNTABILITIES

• Support the process of the annual US Medical Research strategy for assigned therapeutic areas in collaboration with US Medical Research Leadership, Therapeutic Area Medical Directors, Scientific Directors, Clinical Science Lead, as applicable, and oversee allocation of the research budget.

MACS Studies:

• Manage receipt, processing and meetings required for study concept and protocol submissions. Provide final approval for research committee materials including study concepts and protocols, meeting minutes, and team communications.
• Manage operations of the internal CTMSVeeva for studies per Medical SOPs and processes and propose process improvement.
• Support implementation of all Clinical Study Manager and external resource activities to ensure Company Sponsored studies are conducted in GCP compliant and quality manner following all company processes and applicable laws.
• Support Study Execution Team to lead Company Sponsored Studies forward to achieve objectives within target timelines and budget.
• Support study contracts and finances including budget forecasting, contract execution and management, change order processes and improvement, invoicing and accruals.
• Participate in SOP development to ensure US Medical has current processes relevant to current work and future developments.
• Responsible for the tracking and communication of important outputs, performance metrics, and accomplishments related to US Medical external research studies within assigned TA.
• Communicate with important team members (including US Medical Therapeutic Area Medical Directors, Scientific Associate Directors, Liaisons, external investigators) to resolve and discover cause for study related issues. Support the efficient and compliant functioning of the US Medical Clinical Research program within assigned therapeutic area.

Collaborative Studies:

• Manage receipt, processing and meetings required for study concept/synopsis, protocol development and submissions. Provide final approval for research committee materials including study concepts and protocols, meeting minutes, and team communications.
• Support processes for studies per Medical SOPs and applicable laws and propose process improvement.
• Support medical and research team to lead research forward to achieve objectives within target timelines and budget.
• Manage collaborative study contracts and finances including budget forecasting, contract execution & management, change orde