Senior Director, Clinical Monitoring

Your New Company!
At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them.  No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you’re a recent college graduate or seeking your next career opportunity, it’s time to discover your future at Altasciences.

We are better together and together We Are Altasciences.

About The Role

The Senior Director, Clinical Monitoring provides leadership in the strategy development and implementation for their assigned function. They oversee the management and delivery of clinical site oversight and monitoring. They oversee all clinical monitoring activities, ensuring compliance with regulatory standards and the successful execution of clinical trials. This role involves strategic leadership, management of Clinical Research Associates (CRAs), and collaboration with cross-functional teams to maintain high-quality monitoring practices throughout the clinical trial lifecycle.

What You'll Do Here

• Develop and execute on long- and short-term strategy for department establishing timelines, standard operating procedures (SOPs), tools, and guidance documents necessary to execute required activities and provide deliverables in accordance with regulatory guidelines as well as internal and external requirements.

• Oversee the planning, execution, and reporting of monitoring visits to ensure compliance with Good Clinical Practice (GCP) and regulatory requirements.

• Ensure department teams are equipped with the resources, tools, and systems necessary to execute required activities and provide final deliverables in accordance with regulatory guidelines as well as internal and external requirements.

• As needed, review and approve monitoring visit reports, ensuring timely follow-up on action items identified during visits.

• Collaborate with Project Management and other departments to ensure alignment on study objectives, timelines, and deliverables.

• Identify opportunities for process enhancements and lead efforts toward continuous improvement in clinical monitoring practices through intradepartmental and interdepartmental initiatives focusing on efficiency and quality.

• Grow and expand services to achieve business directives and serve our sponsors.

• Attract, retain, and develop talent needed to effectively support site monitoring services.

• Lead and mentor a team of CRAs, providing guidance on clinical trial protocols and site management.

• Manage performance metrics and ensure adherence to monitoring plans.

• Monitor overall departmental performance to identify issues and maintain, update, and analyze metrics.

• Oversee the budget and financial performance of the department.

• Serve as contact for issue escalation, audits/ regulatory inspections, process improvement, and strategy and ensure timely communication of any significant issues.

• Facilitate communication between CRAs and study teams to address any site-related issues promptly.

• Support Business Development and Marketing activities for department.

• Maintain familiarity with client and industry expectations.

• Maintain understanding of regulatory guidelines of related authorities (Therapeutic Products Directorate [TPD], Food and Drug Administration [FDA], European Medicines Agency [EMA], etc) as well as International Conference on Harmonisation (ICH), GCP, and GLP procedures.

• Represent Altasciences in scientific meetings, conferences, and workshops/courses and presents scientific posters in alignment with the strategic objectives of the company, as required.

• Other duties as assigned.

What You'll Need to Succeed

• Bachelor’s degree in a related area of study, ideally an advanced degree. Pertinent experience may be considered in lieu of education.

• Minimum of 10 years of experience in clinical research with at least 5 years of experience in a leadership role.

• Demonstrated ability to manage a team – including attracting, retaining, and developing a high performing team.

• Excellent verbal and written communication skills.

• Professional attitude and strong interpersonal skills.

• Ability to work well with a multi-discipl