Director, Clinical Research & Trials Strategy

Boys Town; Omaha (NE); Sur place; USD 120 000 - 180 000; Plein temps

Résumé du poste

Boys Town National Research Hospital is seeking a senior leader to oversee clinical trials research programs and initiatives. This role drives strategy, planning, and execution across trials, ensuring regulatory compliance and data integrity.

The position leads a multidisciplinary team, coordinates with medical professionals and regulatory affairs, and reports progress to senior management, aiming to advance Boys Town's research objectives and patient care outcomes.

Qualifications

• Advanced degree in medical sciences or life sciences required.
• Minimum eight years of clinical research experience with leadership roles.
• CITI certification within 30 days of hire required.

Responsabilités

• Develops and implements the clinical research strategy and operating plans.
• Leads and mentors a team of clinical research professionals.
• Oversees trial design, protocol development, and regulatory compliance.
• Manages submissions to FDA and other regulatory authorities.
• Collaborates with investigators to select trial sites and investigators.
• Maintains internal monitoring for data management and risk review.
• Ensures adverse event reporting aligns with guidelines and data integrity.
• Oversees SOPs to ensure quality and safety of participants.

Connaissances

Leadership

Strategic planning

Regulatory affairs

Cross-functional collaboration

Budget management

Communication

Formation

Advanced degree (Ph.D./Pharm.D./MD/RN)

Outils

Clinical trial management systems (CTMS)

EDC / data management tools

Description du poste

Boys Town National Research Hospital is seeking a senior leader to oversee clinical trials research programs and initiatives. This role drives strategy, planning, and execution across trials, ensuring regulatory compliance and data integrity.

The position leads a multidisciplinary team, coordinates with medical professionals and regulatory affairs, and reports progress to senior management, aiming to advance Boys Town's research objectives and patient care outcomes.