Senior Clinical Trial Specialist
About The Position
The Senior Clinical Trial Specialist (CTS) is responsible for the design, planning, execution and leadership of clinical studies and clinical programs worldwide as well as leading cross functional clinical teams in support of the organization's business objectives for product development and/or commercialization. The Sr.CTS also provides support in enrollment, follow-up and closure of clinical trial activities through collaboration with Trial Operations, Regulatory Affairs and the Contract & Budget teams, and with divisional and regional clinical teams.
Requirements
- Minimum Bachelor's Degree, or an equivalent combination of experience and education
- Proven clinical trial research experience in a medical device industry required
- Minimum 3 years of experience in Clinical Trials required
- Proven working experience with clinical trial teams, regulatory teams, global Clinical operations, and clinical research site personnel
Nice To Haves
- Experience working with Clinical Trial Management and Electronic Data Capture systems
- Electrophysiology experience preferred
- HCP contracting experience preferred
Responsibilities
- Trial Leadership: Provides project leadership and scientific expertise throughout the development and implementation of local or global clinical studies by supporting the trial manager with writing study protocols, protocol amendments, informed consents, clinical study project timelines and scientific papers for publication by evaluating scientific literature and publications, analyzing scientific data and staying abreast of current clinical practice. May lead studies executed by a CRO.
- Trial Execution: Interacts with various study support groups in order to assist in clinical strategy, the development of study plans, and project deliverables. Communication Ensures clear written communication to clinical sites and facilitates communication between Sales and Marketing, R&D, Regulatory Affairs, Training, Senior Management, Key Opinion Leaders/investigators through team meetings, study memos, and general correspondence (e.g. newsletters).
- Collaboration: Participates in study-specific meetings, teleconferences and trainings. Collaborates with cross-functional team members and study sites throughout all study phases.
- Data Analysis Presents scientific data by communicating accurate, succinct summaries of clinical study work at study specific meetings, industry gatherings, investigational meetings and regulatory agency meetings. May author scientific abstracts and/or publications.
- Regulatory Compliance: 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. Support regulatory inspection activities as required.
- Documentation: Manages study contracts and invoices, request / collection of relevant (i.e. Regulatory Docs, FDF, CV/ML) investigator / site documentation, review and approval of subset of documents in applicable database. Performs healthcare provider contracting and invoice reconciliation for study committee members.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Merchant Wholesalers, Durable Goods
Number of Employees
5,001-10,000 employees
