Clinical Trial Manager

About the role

This position is member of the clinical study team supporting research activities. It is responsible for driving and managing clinical studies to support marketing and regulatory needs. This position will be a primary communication liaison between organization and customers participating as investigational sites on clinical studies. This position will also oversee project management and will delegate tasks to the clinical team members according to project plan. This position will comply with regulations and ensure clinical activities comply with organizational SOPs and global regulatory requirements.

Responsibilities

• Manage and oversee clinical studies from concept to study close out
• Contribute to development of clinical strategy; including Clinical Evidence Plans (CEP) and Clinical Development Plans (CDP)
• Develop clinical investigation plans for regulatory and marketing purposes
• Develop and oversee project plans and budgets
• Conduct initiation and site qualification visits
• Responsible for managing site selection and activation (IRB, agreements negotiations and legal review, etc)
• Responsible for overseeing development of clinical databases, data management plans including data preparation, data validation activities, etc
• Responsible for clinical site management
• Develop monitoring plan and monitor sites for compliance with regulations
• Act as clinical representative on cross-functional product development team
• Complete clinical reports to support ISO and FDA requirements
• Support development of Clinical Evaluation Reports (CERs) as assigned
• Process and review clinical study data using Good Clinical Practices (GCP) data-handling procedures and guidelines.

Requirements

• 5-7 years of experience within clinical research, preferably with medical devices
• Bachelor’s degree (preferably in health science or biotech area)
• Experience with clinical trial management, specifically - site activation, site management, monitoring and contract negotiation
• Experience with ISO, FDA, GCP, and/or MedDev regulations and guidance for trial-related activities
• Strong interpersonal and relationship-building skills
• A collaborative mindset and strong motivation to make it easier for others to do great work
• Ability to communicate with and drive efforts from external partners, such as health care providers
• Self-driven with a structured and detail-oriented approach
• Proficient in Microsoft Office applications including Word, Excel and PowerPoint

Qualifications

• Strong interpersonal and relationship-building skills
• A collaborative mindset and strong motivation to make it easier for others to do great work
• Ability to communicate with and drive efforts from external partners, such as health care providers
• Self-driven with a structured and detail-oriented approach
• Proficient in Microsoft Office applications including Word, Excel and PowerPoint

Skills

• Strong interpersonal and relationship-building skills
• A collaborative mindset and strong motivation to make it easier for others to do great work
• Ability to communicate with and drive efforts from external partners, such as health care providers
• Self-driven with a structured and detail-oriented approach
• Proficient in Microsoft Office applications including Word, Excel and PowerPoint

Benefits

Health and Wellness: Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy. Plus, access to company sponsored wellness programs and mental health resources, paid leave of absence for qualifying events and generous paid parental leave for both birthing and non-birthing parents.

Financial Security: A competitive 401(k) plan with company match that vest immediately, financial planning services to help you secure your future, and corporate discount programs for goods and services.

Work-Life Balance: Generous paid time off, flexible work hours, and flexible work arrangement options to help you balance your personal and professional life may be available.

Professional Development: Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.

Recognition and Rewards: Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.

Sustainability strategy that outlines our ambitions for how to run our company in a more sustainable way.

Competitive Compensation: The compensation range for this position is $108,191 - $162,287. Actual compensation is influenced by a variety of factors including but not limited to skills, experience, qualifications, and geographic location.