Clinical Research Associate Manager SMM

Role: Clinical Research Associate Manager SMM

Type: Field - USA

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.

Typical Accountabilities

• 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

Qualifications

• 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. Study leadership and/or line management preferred.
• 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%.

The annual base pay for this position ranges from $137,937.60 - $206,906.40 Annual USD. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.