Sr Clinical Trial Specialist Job

About the role:

Responsible forthe design, planning, execution and leadership of clinical studies and clinical programs worldwide. Responsible for leading cross functional clinical teams in support of the organization's business objectives for product development and/or commercialization. Possesses a technical knowledge of products, processes, and regulatory requirements for clinical trials conducted within a given therapeutic area.

Yourresponsibilities include:

• Owns Study Design and Strategy Implementation. Able to appropriately solicit and synthesize cross-functional inputs, weigh trade-offs, and lead study decisions which enable all aspects of design & execution to deliver the desired clinical evidence. Able to collaborate cross-functionally to develop study protocols that obtain data critical to support business needs, such as product approval, PMCF requirements, labeling/claims, publications, and protection of patient safety. Able to weigh trade-offs between effective vs efficient, and ultimately drive to an optimized solution which preserves the study's scientific integrity and data quality.
• Provides project leadership, clinical research domain expertise and scientific aptitude throughout the development and implementation of local or global clinical studies. May lead studies executed by a CRO.
• Responsible for ethical and compliant trial conduct in accordance with principles of Good Clinical Practice, including coordination of all clinical trial reporting requirements. Observance of data integrity and quality principles throughout the trial lifecycle.
• Provides clinical input for new product development, post market surveillance, recertification and business development. Interacts with various study support groups in order to assist in clinical strategy, the development of study plans, and project deliverables.
• Interacts with regulatory agencies as needed and will use their scientific knowledge in order to provide directives to staff as well as study sites.
• Facilitates communication between Sales and Marketing, R&D, Regulatory Affairs, Training, Senior Management, Key Opinion Leaders/investigators and investigational sites by conducting team meetings, drafting and sending routine correspondence (e.g., newsletters) and by presenting regular updates to senior staff (BPT/PIB, etc.).
• Manages vendor contracts and works with Project Managers to ensure expenditures are within budgetary guidelines.
• Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.
• Presents scientific data by communicating accurate, succinct summaries of clinical study work at industry gatherings, investigational meetings and regulatory agency meetings.

• Provides accurate progress reports on clinical projects by writing assigned clinical portions of reports for submission to regulatory agencies, Institutional Review Boards, Medical Ethics Committees, etc. May include clinical risk management activities including input into Hazard Analyses, product FMEA and DFUs and authorship of Clinical Evaluation documents (CES, CRBA, CDSR) for identification of harms and support of safety performance for product approval.

  What we're looking for:

  Basic Qualifications

• Bachelor's degree and 5 years of related work experience or an equivalent combination of education and work experience.

• Clinical research experience required.

  Preferred Qualifications

• CRM Clinical trial or technical experience desired.

• Strong preference for a professional with a wide-range of experience and expertise in a specialized technical field.
• Ability to apply comprehensive technical knowledge of a particular field to resolve complex issues in creative ways.
• Ability to use in-depth knowledge of business unit functions and cross-functional group dependencies/relationships.

GE 01-2021