Clinical Operations Manager, Biopharmaceutical Industry
7 days ago
We are seeking an experienced Clinical Operations Manager to join our team at 35Pharma, a clinical-stage biopharmaceutical company dedicated to developing innovative therapeutics for life-threatening lung diseases and musculoskeletal and metabolic disorders.
The successful candidate will be responsible for overseeing clinical monitoring activities, ensuring compliance with clinical protocols, study procedures, and regulatory requirements. This includes conducting on-site and remote monitoring visits, reviewing and collecting essential documents, and serving as the primary point of contact with clinical sites.
Key Responsibilities:- Support clinical sites in patient recruitment initiatives and site-specific plans
- Conduct on-site and remote monitoring visits, including site qualification, initiation, interim, and close-out visits
- Prepare or review confirmation and follow-up letters to investigators and monitoring visit reports
- Participate in the preparation and review of study documents, such as clinical protocols, informed consent forms, and laboratory manuals
- Evaluate and select new CRAs, conduct orientation, and provide continuous training
In this role, you will also be responsible for implementing corrective actions, escalating issues related to quality performance, and maintaining accurate records.
Requirements:To succeed in this position, you will need:
- A Bachelor's degree in health sciences, nursing, or equivalent experience
- A minimum of 2 years' experience in a pharmaceutical or biotechnology company or CRO, with a background in clinical research associate roles
- Strong communication, interpersonal, and problem-solving skills
- Excellent time management, organizational, and attention-to-detail skills
- Proficiency in required software, clinical trial systems, and computer skills
The estimated salary range for this role is between $85,000 and $120,000 per annum, depending on experience. Additional benefits may include bonuses, health insurance, retirement plans, and opportunities for professional growth and development.
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