Senior Clinical Study Manager
WFA Digital Insight
In the current remote job market, demand for clinical study managers with digital skills is on the rise, driven by the need for innovative cancer diagnostics. With the global pandemic accelerating the adoption of remote trials, professionals with expertise in clinical trial execution are in high demand. Danaher, a leader in life sciences and diagnostics, stands out for its commitment to innovation and impact, making this role an exciting opportunity for those passionate about transforming lives. Before applying, candidates should be aware of the essential requirements, including a strong understanding of regulatory requirements and study execution.
Job Description
About the Role
The Senior Clinical Study Manager position at Danaher is a remote role that entails leading clinical trial execution within the US and EU regions for Leica Biosystems. As a key member of the Clinical Development team, this role reports to the Senior Manager, Clinical Programs. The successful candidate will be responsible for independently leading end-to-end study planning and operational delivery, ensuring alignment with regulatory requirements, timelines, and quality standards.This role is critical to the development of diagnostic solutions that aid in the acceleration of next-generation, life-changing therapies. The Senior Clinical Study Manager will serve as the central point of accountability for study execution, collaborating cross-functionally and with external partners to drive progress, resolve issues, and achieve critical program milestones.
As part of the Clinical Development team, the Senior Clinical Study Manager will be part of a diverse and collaborative global community, inspired each day to stretch, grow, and make an impact. The team is passionate about transforming lives and empowering clinicians with innovative, reliable solutions.
What You Will Do
- Provide strategic oversight into the operational planning and execution of complex programs and individual In Vitro Diagnostics (IVD) clinical studies from concept to close-out
- Oversee site and vendor selection and management activities for clinical trial services, ensuring contracts, scope of work, and performance metrics align with study objectives and Standard Operating Procedures (SOPs)
- Develop and implement comprehensive study operational plans, including timelines, budgets, resource allocation, and risk mitigation strategies
- Establish and maintain robust communication channels with investigators, site staff, internal stakeholders, and external partners
- Conduct regular reviews of clinical study data, site monitoring reports, and operational metrics to identify trends, ensure data integrity, and proactively address any performance or quality issues
- Act as a key point of contact and actively support internal and external audits and regulatory inspections
- Develop and write clinical study protocols, informed consent forms, and other essential study documents
- Collaborate cross-functionally to drive progress, resolve issues, and achieve critical program milestones
- Ensure adherence to protocols, Good Clinical Practice (GCP), and regulatory requirements
What We Are Looking For
- Bachelor’s degree in Life Sciences, Healthcare, or a related field with 8+ years of work experience or Master’s degree with 6+ years of related experience
- Demonstrated comprehensive understanding of regulatory requirements, study execution, data integrity, and strategic planning
- Strong project management skills, with the ability to lead cross-functional teams and manage multiple projects simultaneously
- Excellent communication and interpersonal skills, with the ability to build strong relationships with internal and external stakeholders
- Strong analytical and problem-solving skills, with the ability to identify trends and proactively address issues
- Experience with clinical trial management systems and electronic data capture systems
- Strong knowledge of Good Clinical Practice (GCP) and regulatory requirements
- Ability to work in a fast-paced environment and adapt to changing priorities
Nice to Have
- Experience with risk-based monitoring and centralized monitoring
- Knowledge of FDA regulations and guidelines
- Experience with clinical trial budgeting and financial management
- Certification in clinical research or a related field
Benefits and Perks
- Competitive salary and benefits package
- Opportunity to work remotely and flexible working hours
- Comprehensive health insurance and retirement plan
- Paid time off and holidays
- Professional development opportunities and training programs
- Collaborative and dynamic work environment
- Recognition and reward programs for outstanding performance
- Access to cutting-edge technology and tools
How to Stand Out
- To stand out as a candidate, highlight your experience with clinical trial management systems and electronic data capture systems, as well as your knowledge of Good Clinical Practice (GCP) and regulatory requirements.
- Make sure to tailor your resume and cover letter to the specific job requirements, and be prepared to provide examples of your experience and skills during the interview process.
- It’s essential to have strong project management skills, so be prepared to discuss your experience leading cross-functional teams and managing multiple projects simultaneously.
- Familiarize yourself with the company’s products and services, and be prepared to discuss how your skills and experience align with their mission and values.
- Consider obtaining certification in clinical research or a related field to demonstrate your expertise and commitment to the field.
- Be prepared to discuss your experience with risk-based monitoring and centralized monitoring, as well as your knowledge of FDA regulations and guidelines.
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