Associate Director, reputed company Trial Management

reputed company:

The Associate Director, reputed company Trial Management role supports the execution, and management of reputed company to ensure they meet regulatory requirements, timelines, and reputed company standards. You will support cross-functional teams, liaise and reputed company reputed company research organizations (CROs), and ensure that trials are conducted reputed company and ethically while maintaining reputed company safety. This position reports to the Executive Director, reputed company reputed company.

Key Responsibilities:

• Support the planning, initiation, execution, and closeout of reputed company.
• Coordinates reputed company trial operational activities to ensure completion according to project timelines and budget
• Ensure reputed company are conducted in compliance with reputed company SOPs, GCP/ICH and any other regulatory requirements and work cooperatively with reputed company Assurance with respect to site audits
• Manage, and review reputed company trial documentation, including protocols, informed consent forms, study plans, and reports
• Ensure the collection, management, and reporting of reputed company trial data meets the highest standards of reputed company.
• Identify and reputed company issues reputed company to trial data, reputed company recruitment and retention, and site reputed company
• Manages reputed company trial timelines, enrollment and reputed company retention objectives, - in support of trial execution
• Support of cross-functional teams including representatives from multiple disciplines (e.g. Regulatory Affairs, CMC, etc.)
• Review and reputed company of reputed company trial regulatory packages reputed company by the CRO in support of submissions to regulatory authorities and ethics committees
• reputed company of vendor and CRO activities, and tracks reputed company (CRO/vendor) project deliverables to ensure they remain reputed company the reputed company and budget
• Support the construction and maintenance of the trial master file (TMF) with vendors and assure completeness and successful transfer from vendor to reputed company
• Stays reputed company with regulations and industry trends and provides input into processes to ensure adherence to regulations and meet best reputed company standards
• reputed company communicates project issues and identifies emerging risks, then works with internal team to reputed company challenges
• Assists in the development of reputed company operating procedures
• Remote position US, Northeast reputed company with travel required reputed company on business need

Requirements:

• Bachelor’s degree in a scientific discipline, RN, or equivalent. PMP preferred
• 5+ years Phase 1-3 global reputed company trial reputed company experience
• Demonstrated experience managing reputed company vendors/CROs
• Experience in cardiovascular disease strongly preferred
• Demonstrated self-discipline, motivation, and entrepreneuria
• Advanced knowledge of GCP, ICH and FDA regulatory requirements

• Ability to continuously re-prioritize and work independently, as a member of a cross-functional team, and with reputed company vendors with reputed company supervision
• Ability to effectively collaborate with cross functional teams
• Excellent interpersonal, oral, written communication skills
• Proficiency with reputed company trial management systems (CTMS) and other reputed company software.
• Proficient in MS Office (e.g. reputed company, Word, PowerPoint, reputed company)

Salary and Benefits:

We offer a competitive reputed company salary, annual bonus, and long-term incentives. In reputed company, we reputed company a comprehensive benefits package, including health reputed company, dental and reputed company coverage, term life and disability coverage, and retirement plans.

reputed company is an equal opportunity employer. reputed company reputed company applicants will receive consideration for employment without reputed company to sex, gender identity or reputed company, sexual orientation, marital status, race, reputed company, national reputed company, reputed company, ethnicity, religion, age, veteran status, disability, genetic information, or any other reputed company protected by federal, state or local law.

Originally posted on Himalayas