ApplyDescription
SUMMARY: The Regional Site Director (RSD) is critical to ensuring the operational success of Elligo by ensuring the successful operations of all the sites within a geographical region. The RSD is fully responsible for the overall management of all the sites, engaged employees, studies, Principal Investigators (PI) relationships, enrollment, revenue, and the quick start up of new studies. This role is primarily responsible for quick implementation at study start, enrollment, and coordination of research and administrative procedures for the successful management of clinical trials for sites within the region.
The RSD will manage the essential functions at each site, meeting timelines and enrollment deliverables, and regulation compliance. Additionally, RSD is responsible for finances of the region which include the resourcing and management of clinical studies to ensure they are delivered efficiently on time, within budget, while upholding quality expectations. Elligo has highs standards for ensuring studies meet the expectations of all studies and are done in an audit ready manner. Additionally, the RSD must be an out of the box thinker, to implement processes and solutions that are simple, reduce redundancy, and multiple touchpoints, and are strong problem solvers and strong relationship builders with excellent communication skills and care about his/her employees who can develop people.
The RSD will also have study management and therapeutic expertise across the organization to have in depth knowledge of his/her sites and be able to present their abilities to sponsors.ESSENTIAL DUTIES:
- Actively manage several sites across a large geographical region and create an internal and external brand of leadership and professionalism.
- Successfully manage the operational budget and meet/exceed the site’s financial, operational, and study-specific targets.
- Create and define KPI’s and critical reporting metrics for the region and ensure all employees are tied to them to ensure success.
- Ensure high operating standards and results over (24/7) operations and management of clinical research trials at the sites under your responsibility.
- Ensure sites profiles are up to date within MarketPlace.
- Ensure timely and appropriate communications occur with Sponsors, CROs and IRBs as necessary.
- Develop site staffing plans to ensure the successful and efficient conduct of research studies, utilizing traveling staff as necessary.
- Work with the Medical Directors to address any study and/or clinical quality related.
- Manage 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.
- Identify and build relationships with outside medical practices, pharmacies, and other health care professionals/organizations to aid in the patient recruitment process at sites or within the geographical region.
- Identify and implement strategies to expand the research capabilities at the site - in line with the overall site business and growth plans.
- Work with Network expansion to identify additional sites (~1-2 per year in geographic region) to join Elligo Network
- Review site metrics, including assisting in metric collection as needed; investigate and troubleshoot quality issues.
- Evaluates overall performance of the stie and recommends and implements processes and plans for improvement.
- Conduct business development activities, including being client facing to help sell sites within region.
- Serve as an SME to a therapeutic area.
- Ensure completeness, accuracy, and timeliness of Feasibility Questionnaires, CDAs, CVs and essential regulatory documents from sites.
MANANGEMNT RESPONSIBILITIES:
- Coach, develop, and engage employees to ensure they have a pathway to meet their highest potential and that they activity collaborate and support other team members.
- Provide work force planning for each site to ensure there is appropriate staffing and back up. While additionally proactively planning for future needs to ensure you have the highest performing team to meet the department goals and ensure
- Assess the work performance of employees and identify areas that need improvement.
- Set and communicate expectations and goals for the department and individuals that connect back to company/departments strategic goals, vision, and values. Ensure each employee understands how their work aligns and contributes to the company’s overarching goals and success.
- Ensure that business goals, deadlines, and performance standards are met according to set benchmarks and established company policy.
- Actively recruit, train, and provide both timely positive reinforcement and feedback as well as constructive feedback to ensure the ability to curb and redirect behavior.
- Able to indirectly manage teams and performance through others. While also matrix managing others and creating strong relationships internally to ensure the department’s needs are met and the work/support needed to be completed by others is done with priority.
RequirementsQUALIFICATIONS:
- Excellent management and leadership skills and innately care and develop employees. Able to assess talent, and recruit and retain talent.
- Able to present to outside sponsor and PI’s and successfully communicate your sites’ strengths and the capabilities of Elligo.
- Proven ability to solve problems, create efficiencies and improve processes and sites capabilities.
- Ability to work cross functionally and with various levels of employees throughout an organization to achieve business results effectively and efficiently.
- Strong project management skills and successfully meeting timelines and budget goals.
- Proactive and timely follow-up skills including the ability to organize applicable department timelines and follow up with internal and external stakeholder needs as needed.
- Excellent written and verbal communication skills, including the ability to present ideas and suggestions clearly and effectively.
- Strong organizational skills, including the ability to manage competing priorities and meet agreed-upon timeframes through effective prioritization of duties and functions in a fast-paced environment.
- Self-motivated; able to work independently to complete tasks respond to department requests and collaborate with others to utilize their resources and knowledge to identify quality solutions.
- Skilled in interacting and working with others, including peers, patients, management, and internal and external stakeholders.
- Well versed and current in ICH GCP, FDA, EMA and other relevant regulations and guidelines that govern clinical trial conduct.
- Working knowledge of Good Clinical Practice guidelines and Federal research regulations.
- The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios, and achieve project timelines while being able to apply your understanding of study protocol(s).
- Strong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), and Electronic Document Management System (EDMS),
- Demonstrated proficiency with Microsoft 365 (Outlook, Word, Excel, PowerPoint, Teams, and SharePoint); ability to understand, adapt, and leverage technology to drive strategic and operational success.
- Honest and ethical work approach to promote the development of life-changing treatments for patients.
- Ability to travel for clinic visits, staff QC activities, team meetings, conferences, or client meetings, as required.
EDUCATION AND EXPERIENCE:
- BS/BA in Life Science or related discipline.
- 12 years’ prior clinical trial, site development experience or relevant experience.
- 7+ years site experience.
- 6 years of experience managing teams and directly or indirectly facilitating workgroups.
- Minimum 12 years of experience customer service experience, with at least 10 years of client relationship management experience.
- 6 years of financial management experience, including overseeing and managing department and site level budgets.
- Experience with clinical trial master filing systems.
ENVIRONMENT:
- This is remote position based on the location of the incumbent’s home. This role routinely uses standard office equipment such as computers, printers, copiers, and phones.
- Less than 25% travel may be required to support the position’s responsibilities.
PHYSICAL DEMANDS:
- The physical requirements described here are representative of those that must be met by an employee to successfully perform the functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is required to:
- Regularly work at a desk using a computer for prolonged periods.
- Perform repetitive motion with substantial movements (motions) of the wrists, hands, and/or fingers.
- Regularly communicate via e-mail, telephone, chat, webcam (remote sessions such as MS Teams or Zoom), so others will understand and exchange accurate and timely information.
- Frequently stand/walk, grasp objects, and perform lightly/fine manipulation of objects.
- Occasionally move safely over uneven surfaces.
- Occasionally reach/work above shoulders, twist/bend/stoop/squat, grasp forcefully, lift/carry/push/pull objects that weigh up to 20 pounds.
ADDITIONAL:Elligo Health Research is a dynamic organization in a rapidly changing industry. Accordingly, the responsibilities associated with this job may change from time to time in accordance with business needs. More specifically, the incumbent may be required to perform additional and/or different responsibilities from those set forth above.The above declarations are not intended to be an all-inclusive list of the duties and responsibilities of the job described, nor are they intended to be such a listing of the skills and abilities required to do the job.
Rather, they are designed only to describe the general nature of the job.The incumbent must be flexible as there may be workweeks that require more than 40 hours to ensure the position’s expectations and responsibilities are met. Elligo Health Research is committed to a policy of equal employment and will not discriminate against an applicant or associate based on his or her age, sex, sexual orientation, gender identity, race, color, creed, religion, national origin or ancestry, citizenship, marital status, familial status, physical or mental disability, handicap, military or veteran status, genetic information, pregnancy or any other category protected under federal, state or local law, regulation or ordinance.
