Associate Director of Clinical Trials

Description

The Associate Director of Clinical Trials is responsible for overseeing the strategic and operational aspects of clinical trials. This role involves managing trial execution, ensuring compliance with regulatory requirements, and driving the development and implementation of clinical trial strategies. The Associate Director will work closely with cross-functional teams, including research, regulatory affairs, finance, and external partners, to ensure the successful completion of clinical trials and advancement of clinical research objectives.

Strategic Planning and Management:

• Develop and implement clinical trial strategies aligned with organizational goals and regulatory requirements.

• Oversee the planning, execution, and completion of clinical trials, ensuring they are conducted efficiently and effectively.

Regulatory Compliance:

• Ensure all clinical trials comply with regulatory guidelines, including FDA regulations, Good Clinical Practice (GCP), and Institutional Review Board (IRB) requirements.

• Prepare and review regulatory submissions, including study protocols, informed consent forms, and regulatory reports.

Team Leadership and Coordination:

• Lead and mentor clinical trial teams, including Clinical Research Coordinators, Clinical Research Associates, and other support staff.

• Foster a collaborative environment among team members and ensure clear communication and alignment on trial objectives.

Study Design and Implementation:

• Oversee the design and development of study protocols, ensuring scientific rigor and alignment with study objectives.

• Coordinate with internal and external stakeholders to ensure timely initiation and progress of clinical trials.

Budget and Resource Management:

• Develop and manage trial budgets, including negotiating and monitoring contracts with vendors and service providers.

• Collaborate with the Finance and Billing Department to ensure accurate financial planning, tracking, and reporting of trial expenditures.

• Allocate resources effectively to ensure the successful execution of clinical trials.

Data Management and Analysis:

• Oversee the collection, management, and analysis of clinical trial data, ensuring data integrity and accuracy.

• Collaborate with data management teams to address data-related issues and ensure compliance with data protection regulations.

Stakeholder Engagement:

• Build and maintain relationships with key stakeholders, including investigators, regulatory agencies, and industry partners.

• Represent the organization at meetings, conferences, and other professional events.

Problem Solving and Troubleshooting:

• Identify and address issues that arise during the conduct of clinical trials, implementing corrective actions as needed.

• Provide guidance and support to resolve logistical and operational challenges.

Reporting and Documentation:

• Ensure accurate and timely reporting of trial progress, including interim and final study reports.

• Maintain comprehensive documentation of trial activities, including protocol amendments, adverse events, and regulatory communications.

Admin duties as assigned by manager

Requirements

Education / Training

 •  Bachelor’s Degree in a Health or Life Sciences-related field (e.g., Biology, Nursing, Pharmacy, Public Health) required.

 •  Master’s Degree in Clinical Research, Public Health, Biology, or a related field, preferred.

 •  Doctoral Degree (PhD, PharmD, MD) in a relevant field is an advantage, preferred.

Licenses / Certifications

CITI Program Training in Good Clinical Practice (GCP) required

CITI Program Training in Human Subjects Protection (HSP) required

Experience Requirements

Minimum of 5-10 years of experience in clinical research, with a focus on clinical trial management, coordination, or regulatory compliance.

Proven track record in leading and managing clinical trials across multiple phases (I-IV) in various therapeutic areas, required.

At least 3-5 years of supervisory or management experience within a clinical research setting, including mentoring and leading a team of clinical research professionals.

Experience with regulatory submissions, including IRB protocols, informed consent forms, and clinical trial agreements.

Demonstrated expertise in developing and implementing standard operating procedures (SOPs) to ensure compliance with FDA regulations and ICH-GCP guidelines.