What are the responsibilities and job description for the Clinical Associate Site Director position at Alliance For MultiSpecialty Research LLC?
Position Overview
The Clinical Associate Site Director is responsible for the independent management and execution of clinical trial operations at the site level. Reporting directly to the Senior Vice President (SVP) of Clinical Operations, this role will be focused on ensuring the smooth coordination and successful execution of clinical trials while meeting all operational, regulatory, and financial targets. The Associate Clinical Site Director will have direct oversight of day-to-day site activities including clinical trial coordination, patient recruitment, site staff management, and ensuring compliance with applicable regulations and AMR’s standards. This role provides a platform for an individual to develop their leadership and management skills in clinical operations with greater responsibility over time.
To consistently embody AMR’s Core Values:
- Excellence and Consistency
- Collaborative Innovation
- Respect for our Subjects, Sponsors, and Team Members
- Community
- Unimpeachable Ethics
Clinical Site Director will report to SVP, Clinical Operations
Classification: Exempt
Primary Responsibilities
- Work with the Senior Vice President, Clinical Operations to Oversee all aspects of clinical trial operations at the site, ensuring trials are conducted efficiently, on time, and within budget. Ensure alignment with operational targets and company goals.
- Ensure financial targets are met and identify cost-saving opportunities.
- Assist with financial forecasting and reporting.
- Oversee the implementation and maintenance of AMR quality standards at the site ensuring that the conduct of clinical studies and the collection of patient data is in accordance with ICH GCPs and AMR SOPs.
- Oversee site staff, ensuring adequate resourcing for clinical trials. Manage staff scheduling, workload distribution, and help identify and address staffing gaps. Work proactively to ensure retention and growth of site personnel.
- Identify and share lessons learned and best practices across programs.
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Provide operational leadership for the site portfolio inclusive of:
- Ensuring achievement of operational and financial targets through active participation in the Risk Review Process and routine review of metrics and KPIs via the available suite of data and reports.
- Ensures quality standards are set and maintained over all areas of responsibility. Ensures adherence to CAPA and QI timelines and outcomes for assigned sites.
- Assist in recruiting new staff, including participation in the interview process. Proactively work to ensure staff retention and turnover rates remain within expected levels.
- Review workload for all staff in the reporting chain, participate in managing the resource availability for the assigned staff, providing support that projects are suitably resourced, and staffing needs are identified in a timely fashion.
- Provide expert operational oversight and guidance to support prioritization of activities, review and monitor the work performed, metric compliance, and development of contingency plans, among others.
- Participate in operational and department level financial reviews.
- Drive the site’s operational decisions, ensuring they align with AMR’s goals and values.
- Participate in department-level meetings, provide updates to the SVP, and contribute to high-level decision-making. Provides oversight to site teams in driving management of financial aspects of assigned studies to ensure adherence to the financial process flow (e.g., executed contracts, forecasting, invoicing, etc.)
- If needed, participate in meetings to discuss escalation with internal/external partners.
- Enables a culture of proactive risk identification and mitigation, rapid issue resolution, a sense of urgency, customer satisfaction and stakeholder collaboration.
- Develop site staffing plans to ensure the successful and efficient conduct of research studies. Identify and fulfill any site resource needs which are necessary to successfully conduct and/or recruit research studies.
- Oversee the performance of site staff members, delegating appropriate and challenging assignments to encourage growth, development and responsibility. Responsible for ensuring the ongoing training needs of site staff members are met.
- Responsible for proper reporting of site revenues and preparation of financial projections in collaboration with Site Manager.
- Share best practices with other AMR site locations with the goal of raising the overall level of operational competencies at AMR.
Desired Skills and Qualifications:
- Bachelor’s degree preferred; Advanced degree suggested or equivalent clinical research.
- Education and Experience
- 5 years of clinical management experience or equivalent applicable experience in clinical research industry Expertise in project management demonstrated ability to successfully manage people/projects. Proactive problem-solving abilities and follow-through
- Knowledge of field organizational strategies - The ability to adapt to a rapidly changing work environment. Successful matrix and remote team management and decision making.
- Extensive knowledge of clinical research - Understands the drug development process and regulatory requirements.
- Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities. Ability to review protocols, programs, and assess the success of a project.
- People management experience includes line management and matrix management.
- Flexibility, with the ability to manage multiple tasks to meet deadlines delivering high quality work in a dynamic, rapidly changing environment.
- Effective communication and presentation skills - Demonstrates strong written and verbal communication skills. Ability to establish and maintain positive Sponsor, team members and internal relationships. Ability to conduct effective presentations.
- Computer skills - Working knowledge of MS Office suite, Clinical Conductor CTMS and relevant CRM Able to generate business correspondence, create forms and generate reports as required.
- Practices professionalism and integrity in all actions – Demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done.
- Ability to communicate effectively in English (both verbal and written).
- Up to 25% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed.
- Other duties as assigned
Alliance of Multispecialty Research does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.