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Full-timeDescription
SUMMARY:
The Clinical Site Manager (CSM) is essential in ensuring Elligo network sites are well-prepared to conduct clinical studies effectively and efficiently. Serving as the primary point of contact for new Elligo Traditional sites, the CSM provides comprehensive study management support across all sites or practices requiring trial assistance. Acting as a strategic partner, the CSM is accountable for each site's success, fostering a strong, collaborative relationship between Elligo and the site. By proactively identifying and addressing challenges, the CSM ensures an optimal and successful partnership and successful trial outcomes.
This role demands exceptional client service skills and the ability to influence and guide senior stakeholders. It requires effectively managing through others, securing buy-in, and providing ongoing education to ensure seamless site support, successful study management, and adherence to all compliance and quality standards. In this role, the CSM is pivotal in strengthening Elligo’s network of sites, driving clinical trial efficiency, and ultimately contributing to the broader goal of advancing healthcare through effective clinical research.
ESSENTIAL DUTIES:
- Build and maintain strong, long-term relationships with physicians, healthcare facility administrators, and key decision-makers within assigned practices
- Strengthen Elligo’s presence by expanding relationships across key personnel, ensuring ongoing collaboration and trust.
- Responsible for a portfolio of 10-12 clinical research sites; variable depending on business needs
- Collaborate with Central Team CTLs, Clinical Site Managers, PIs, and practice-based study staff to ensure smooth study execution.
- Coordinate communication between practices and internal teams to streamline processes and ensure alignment on goals.
- Provide weekly site reports to your portfolio, including recruitment metrics, study performance and study pipeline.
- Drive the growth and development of research programs by engaging new investigators and identifying additional therapeutic areas.
- Collaborate with site staff to ensure recruitment goals are met or exceeded.
- Provide site setup expertise, ensuring that new sites are qualified and prepared to conduct clinical trials efficiently.
- Support the site staff in all trial-related activities, including audits and monitoring visits
- Evaluate site equipment needs and work with internal teams to ensure the appropriate research infrastructure is in place.
- Facilitate pre-study site qualification, study initiation, monitoring visits, and study closeout activities.
- Assist with training and onboarding of new study staff and oversee new Clinical Research Coordinator (CRC) hires for up to six months to ensure competency.
- Serve as the point of contact for study management activities, including feasibility and site qualification visits (PSVs), before a CRC is assigned.
- Serve as the point contact for the site for site-related activities
- Provide weekly and monthly performance reports to sites and practice leadership, including pipeline and financial reports.
- Monitor the delivery of Elligo Powered By services, ensuring timely, accurate, and complete execution.
- Manage documentation for all Elligo Powered By sites, including training, development, and adherence to Standard Operating Procedures (SOPs).
- Work cross-functionally with other departments to ensure cohesive support for practices and the successful execution of clinical trials.
- Collaborate with site staff and Elligo project leads to monitor and ensure the timely, accurate, and complete delivery of Elligo Powered By services.
- Perform other duties as required or assigned.
SUPERVISORY RESPONSIBILITIES:
QUALIFICATIONS:
- Excellent interpersonal skills and proven ability to build strong relationships and work with cross functional groups to effectively achieve business results.
- Ability to work with functional groups and different levels of employees throughout Elligo to achieve business results effectively and professionally.
- 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 verbal and written communication skills, including the ability to effectively convey ideas and information clearly, convincingly, and concisely. Additionally, clear and concise written and oral communication skills, including the ability to present ideas and suggestions clearly and effectively.
- Strong organizational skills, including the ability to accomplish multiple tasks within the agreed-upon timeframes through effective prioritization of duties and functions in a fast-paced environment.
- Proven track record of building and maintaining solid relationships with both internal and external stakeholders.
- Self-motivated with the ability to work independently to complete tasks, respond to department requests, and collaborate with others to utilize their resources and knowledge to identify quality solutions with minimal direction from supervisor.
- Skilled in interacting and collaborating with others, including peers, patients, management, and internal and external stakeholders
- Strengths of character to working with doctors and being able to build relationships while also knowing when to push back and manage senior-level individuals.
- Strong working knowledge of Good Clinical Practice guidelines and Federal research regulations.
- Ability to comply with Elligo, Clinic, and Sponsor policies, Standard Operating Procedures (SOPs), GCP guidelines, and document data according to ALCOA.
- High level of proficiency with clinical trial terminology and practices required
- 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), Electronic Document Management System (EDMS), and MS Office products such as Excel and Word.
- Honest and ethical work approach to promote the development of life-changing treatments for patients.
- Comply with Elligo, Clinic, and Sponsor policies, Standard Operating Procedures (SOPs), GCP guidelines, and document data according to ALCOA.
EDUCATION AND EXPERIENCE:
- Bachelor’s degree (BA/BS) in Life Sciences or a related field or Associate degree with at least 4 years of experience in direct or indirect (such as clinical trials, RWE, life sciences, healthcare) CCRC/CCRP certification is preferred
- Minimum of 3 years of experience in clinical research, preferably in a Clinical Research Coordinator role, with prior clinical research site management experience being ideal.
- Experience managing budgets and contracts is preferred
- Minimum of 3 years of experience in customer service
- Minimum of 2 years of experience in client relationship management
- Experience working with site networks is preferred
- Previous experience with training and mentoring other clinical research professionals on the management of regulatory documents throughout the trial lifecycle is preferred.
ENVIRONMENT:
This is a remote position based on the location of the incumbent’s home and operating in a home-office environment. This role routinely uses standard office equipment such as computers, printers, copiers, and phones.Occasional evening and weekend work may be required as job duties demand.Approximately 30% of 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 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, and 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 light/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.
While performing the duties of this job, the employee is regularly required to sit, stand, walk, use hands and fingers to feel and handle, reach with arms and hands, talk and hear. While performing the duties of this job, the employee is frequently required to stoop, kneel, crouch, lift weights, or exert a force up to a maximum of 40 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 positions 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.RequirementsBachelor’s degree (BA/BS) in Life Sciences or a related field or Associate degree with at least 4 years of experience in direct or indirect (such as clinical trials, RWE, life sciences, healthcare) CCRC/CCRP certification is preferredMinimum of 3 years of experience in clinical research, preferably in a Clinical Research Coordinator role, with prior clinical research site management experience being ideal.Experience managing budgets and contracts is preferredMinimum of 3 years of experience in customer serviceMinimum of 2 years of experience in client relationship management Experience working with site networks is preferredPrevious experience with training and mentoring other clinical research professionals on the management of regulatory documents throughout the trial lifecycle is preferred.
