FSP Senior Clinical Development Program Coordinator
Gaithersburg, MD, US
about 1 month ago
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Summary
The Clinical Development Program Coordinator will provide support to the Clinical Development team in the planning, execution, and management of clinical trials and programs.
Responsibilities
Draft written communications, power point presentations, and reports for key senior stakeholders and broad audiences
Coordinate meetings (e.g., clinical sub-team, project reviews), including agendas, slide preparation and meeting notes
Support Clinical Development workstreams and process improvements
Basic project management to coordinate processes, timeline and deliverables
Assist with data entry, basic data analysis, and creation of graphs and visuals
Creation of Purchase orders for vendors, as needed
Oversee senior leaders’ schedules, screen for conflicts, organize meetings, and prioritize engagements to optimize time management
Collaborate with leadership to prepare materials for program and governance level meetings and other key interactions, ensuring accurate and timely information flow
Assist in tracking milestones, generating program level metrics, and providing written and verbal updates to senior management
Design multi-country travel itineraries and manage travel arrangements, including flights, hotels, ground transportation and expense reports for the team
Provide administrative support as necessary, either unilaterally or in partnership with an executive assistant, to ensure seamless operations and execution of key responsibilities
Work with vendors to finalize SOWs for Clinical Development contractors or functional service provider, as needed
Assist in SOP and working instruction development, review and approval within the company
Support Clinical Development external collaboration activities as needed (e.g., execution of Confidential Disclosure Agreement, development and execution of research collaboration)
Identify and communicate issues that will impact budget, resources and timelines
Qualifications
Good time management, prioritization and multitasking abilities
Strong written and verbal communication skills
Excellent professional presence and interpersonal skills to build strong relationships with executive team members, colleagues and junior staff
Ability to assist in the creation of business processes and project plans, and track items over time
Excellent Microsoft office suite skills
Great strategic planning and problem-solving skills
Ability to support multiple projects and stakeholders simultaneously
Able to work independently on responsibilities of the role
Ability to provide clear status updates
Able to work to high standards, and interact well with all professional levels
Ensure an enthusiastic and open attitude towards continuous professional development
Previous experience of working in Clinical Research either in the Academic, Science, Pharmaceutical or Health-related industry setting preferred
A proven track record of quickly learning new areas, performing in a fast-paced work environment, and being able to successfully multi-task
Bachelor’s degree and 2-5 years of experience in similar role
Demonstrated computer skills; proven functional knowledge of Microsoft packages and ability to develop proficiency in relevant IRT and EDC systems and programs
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