Associate Director Clinical Monitoring

Associate Director, Clinical Monitoring

About WEP Clinical

WEP Clinical is a global leader in the distribution of innovative treatments, with over 15 years of experience serving patients in over 120 countries. We are committed to providing early access to life-changing therapies and fostering a collaborative environment that values leadership and professional growth.

Job Summary

We are seeking a highly motivated and experienced Associate Director, Clinical Monitoring to lead and oversee our clinical monitoring processes. This role will play a critical part in ensuring the quality, efficiency, and compliance of our clinical trials.

Key Responsibilities

• Develop and execute comprehensive site monitoring plans and data collection strategies for clinical trials.
• Lead and mentor a team of clinical research associates (CRAs) and in-house CRAs, fostering a culture of excellence and continuous improvement.
• Oversee monitoring strategies for complex or high-priority studies, ensuring adherence to GCP, ICH guidelines, and global regulatory requirements.
• Manage clinical monitoring budgets and resource allocation effectively.
• Build and maintain strong relationships with sponsors, CROs, and key stakeholders.

Qualifications

• Bachelor's degree in life sciences, healthcare, or a related field.
• Minimum 7 years of experience in clinical research, including 3+ years in a leadership capacity.
• In-depth knowledge of clinical research processes, GCP, ICH guidelines, and global regulatory requirements.
• Proven leadership and people management skills with the ability to influence, guide, and motivate teams.

Benefits

WEP Clinical offers a competitive compensation package including medical, dental, and vision insurance, FSA, HSA, voluntary short-term and long-term disability insurance, voluntary life insurance, 401K safe harbor plan with company match, paid vacation, holiday, and sick time, and paid maternity & paternity leave.

Qualifications

Education:

• Bachelor's degree in life sciences, healthcare, or a related field is required.

Experience:

• Minimum of 7 years of experience in clinical research, including at least 3 years in a leadership role.

Skills & Knowledge:

• Comprehensive understanding of clinical research processes, GCP, ICH guidelines, and global regulatory requirements.
• Proven leadership and people management skills with the ability to effectively influence, guide, and motivate teams.
• Strong communication, interpersonal, and problem-solving skills.
• Experience developing and executing site monitoring plans and data collection strategies.
• Familiarity with clinical monitoring software and technologies.

Key Responsibilities:

Clinical Monitoring Leadership:

• Lead the development and implementation of clinical monitoring processes, ensuring adherence to quality standards and efficient execution.
• Oversee the creation and execution of site monitoring plans and data collection strategies for assigned clinical trials.
• Manage and mentor a team of Clinical Research Associates (CRAs) and In-House CRAs, providing guidance, support, and professional development opportunities.

Study Oversight and Management:

• Directly oversee monitoring strategies for complex or high-priority studies, ensuring timely and accurate data collection and reporting.
• Manage clinical monitoring budgets and resource allocation, optimizing resource utilization and cost-effectiveness.

Stakeholder Collaboration:

• Build and maintain strong relationships with sponsors, Contract Research Organizations (CROs), and other key stakeholders, fostering effective communication and collaboration.
• Represent WEP Clinical in meetings and discussions with sponsors and regulatory agencies, effectively communicating study progress and addressing any concerns.

WEP Clinical - Associate Director Clinical Monitoring: Hiring Workflow

1. Application Review: Qualified candidates will be screened based on their resume and cover letter, focusing on relevant experience, skills, and education.

2. Phone Screening: Shortlisted candidates will participate in a phone interview to assess their communication skills, experience, and fit with the company culture.

3. Skills Assessment: Candidates will complete a skills assessment to evaluate their knowledge of clinical research processes, GCP, ICH guidelines, and regulatory requirements.

4. In-Person Interview: Top candidates will be invited for an in-person interview with the hiring manager and potentially other team members. This will involve behavioral questions, technical discussions, and a presentation opportunity.

5. Reference Checks: Finalists will undergo reference checks to verify their experience and work ethic.

6. Offer & Onboarding: The selected candidate will receive a formal offer letter outlining compensation and benefits. Upon acceptance, the onboarding process will begin, including paperwork, training, and introductions to the team.

About WEP Clinical

WEP Clinical is a global leader in the pharmaceutical distribution industry, with over 15 years of experience delivering innovative treatments to patients in over 120 countries. Driven by a commitment to patient access and a collaborative work environment, WEP Clinical fosters a culture that values leadership and empowers employees to make strategic contributions.

We believe in providing our team with opportunities for professional growth and development, alongside a comprehensive benefits package that includes medical, dental, and vision insurance, a 401K safe harbor plan with company match, paid time off, and more. Join WEP Clinical and be a part of a company dedicated to improving lives through access to groundbreaking therapies.