Clinical Research Associate Manager SMM

AstraZeneca

4d • $137,938 - $206,906 • Onsite

About The Position

Direct functional line management of a group of Clinical Research Associates within US Site Management and Monitoring. Accountable for the successful execution of clinical trials including resource allocation, adherence to timelines and compliance with all SOPs, policies and regulatory requirements. Oversees project assignments, workload distribution and problem resolution with direct reports. Interacts with other team management and functions as needed.

Requirements

• University degree in related discipline, preferably in life science, or equivalent qualification.
• 8 years of clinical trial experience with at least 4 years of site monitoring.
• Fluent knowledge of spoken and written English.
• Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
• Good knowledge of relevant local regulations.
• Good medical knowledge in relevant AZ Therapeutic Areas.
• Basic understanding of the drug development process.
• Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
• Ability to travel required, approximately 15%.

Nice To Haves

• Study leadership and/or line management preferred.

Responsibilities

• Responsible for performance management and development including talent development, coaching, mentoring and providing routine feedback.
• Interviews, hires, develops and trains staff on AZ SOPs, policies and procedures.
• Communicates regularly with contract staff managers to provide feedback on contract staff performance.
• Evaluates and projects resource needs on an on-going basis based on portfolio.
• Ensures the implementation of clinical studies through efficient allocation of CRAs.
• Ensures close working relationship within US SMM including other CRA managers and Clinical Research Managers as well as other key internal/external stakeholders.
• Responsible for ensuring adequate, timely and compliant monitoring, site management and oversight for assigned CRAs.
• Conduct regular (twice annually) quality visits with each employee CRA.
• Communicate with staff on program changes, policy changes, and priority shifts on a regular basis.
• Be aware of issues affecting staff’s workload and efficiency.
• Collaborate with colleagues and US leadership team as needed for escalation and support for resolution.
• Review and approve expenses; assure expense reports are being submitted on a timely basis and are in compliance with the company's policies.
• Conduct regular staff meetings and participate in Management staff meetings.
• Leads special initiatives as needed.
• Partner with key operational sites to develop/enhance AZ relationship.
• Participate in training and mentoring of new members of the local Study Delivery Team ensuring compliance with ICH/GCP and AZ Procedural documents.
• Contribute to process improvements, knowledge best practice sharing

Benefits

• short-term incentive bonus opportunity
• equity-based long-term incentive program (salaried roles)
• retirement contribution (hourly roles)
• commission payment eligibility (sales roles)
• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Manager