Clinical Site Director - Remote

Alliance For MultiSpecialty Research LLC•Knoxville, TN

3h•Remote

About The Position

The Clinical Site Director is responsible for managing the overall business and clinical operations of individual sites to ensure that appropriate targets are met. The Clinical Site Director is responsible for managing the site’s annual and forecast operating budgets and for the efficient coordination, organization and conduct of clinical trials. The Clinical Site Director oversees and manages all aspects of the clinical trial process including study feasibility, clinic staffing, patient recruitment, study conduct, quality, and regulatory compliance in collaboration with respective functional groups. This individual will work closely with senior leadership, site investigators, and external stakeholders to guide AMR in developing innovative, ethical, and high-quality research programs. To consistently embody AMR Clinical’s Core Values: United We Achieve Celebrate Diverse Perspectives Do the Right Thing Adapt and Persevere

Requirements

Bachelor’s degree preferred; Advanced degree suggested or equivalent clinical research.
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.
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.
Fluent in English

Responsibilities

Work with the Senior Vice President, Clinical Operations to manage the operational budget and meet/exceed the site’s financial, operational, and study-specific targets.
Ensure financial targets are met by optimizing resource allocation and identifying cost-saving opportunities.
Identify and implement strategies to expand the research capabilities at the site - in line with AMR’s overall business and growth plans.
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
Accountable for ensuring delivery across multiple sites according to the contracted scope, timeline, and budget, in accordance with AMR’s SOPs, GDP, GCP, and ICH guidelines and all applicable regulations.
Identify and share lessons learned and best practices across programs, building relationships with key stakeholders cross-functionally, across all levels.
Provide technical and operational leadership for the site portfolio inclusive of: 1. 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. 2. Ensures quality standards are set and maintained over all areas of responsibility. Ensures adherence to CAPA and QI timelines and outcomes for assigned sites. 3. Identify opportunities to expand into new therapeutic areas. 4. Assist in recruiting new staff, including participation in the interview process. Proactively work to ensure staff retention and turnover rates remain within expected levels. 5. 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. 6. 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. 7. Participate in operational and department level financial reviews. 8. Identify potential risks to trial progress or site performance and lead efforts to mitigate those risks. Handle operational challenges independently and escalate issues to the SVP when necessary.
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.)
Serve as an escalation point for sites, customers and internal partners. If needed, participate in meetings to discuss escalation with internal/external partners.
Rapidly identify key issues in complex situations. Includes and leads appropriate participation in informal problem-solving teams when appropriate and brings alternatives integrated viable solutions for business.
Acts as a liaison and facilitator between other functional areas for overall operational issues.
Enables a culture of proactive risk identification and mitigation, rapid issue resolution, a sense of urgency, customer satisfaction and stakeholder collaboration.
Demonstrated ability to drive strategic operations decisions with multiple stakeholders.
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.
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.
Collaborate to develop the patient recruitment plan and patient outreach process. Ensure adjustments/modifications to recruitment strategies are executed based upon the timely review of results to ensure financial and study-specific targets.
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.
Conduct business development activities on behalf of the site and AMR with sponsors, CROs, CRAs and any third-party study vendors, as appropriate.
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.