Site Director

Linden Capital Partners • $90K — $120K *
Miami, FL 33186In-Person
Healthcare
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • B.A. or B.S. required; advanced degree preferred.
  • Minimum of 3 years' experience in managing clinical trials.
  • Knowledge of regulatory requirements, GCP, HIPAA, and ICH guidelines.
  • Strong communication skills to collaborate with diverse stakeholders.
  • Proficient in medical terminology for effective dialogue with clinical teams.
  • Experience managing clinical staff and fostering a productive work environment.
  • Capability to work independently, making informed decisions within guidelines.

Responsibilities

  • Supervise and mentor direct reports, overseeing HR functions.
  • Develop and implement strategic business plans with site Operations lead.
  • Ensure compliance with quality management and operational guidelines.
  • Participate in Business Development calls to assess site pipeline.
  • Oversee subject recruitment planning and database management.
  • Prepare and submit regulatory materials to relevant organizations.
  • Contribute to management of clinical research studies and support services.

Benefits

  • Training programs to enhance employees' job performance.
  • Opportunities for community outreach participation.
  • Support for continuous education and professional development.
Full Job Description
Job Description:

The Site Director is responsible for the profitable management of the clinical research business, consistent with company policies, principles, strategies, and objectives. Accountable for the overall coordination, organization, and efficient implementation of clinical trials management, operations, and regulatory compliance. Works closely with the Chief Operating Officer, Therapeutic Lead, Chief Medical Officer, Principal Investigators, Recruitment Team and Clinical Research Coordinators to evaluate clinical trials and ensure that all study-related procedures are completed properly from a clinical and a regulatory perspective. In executing these position responsibilities, the Site Director is guided by Good Clinical Practices (GCP), International Committee on Harmonization (ICH) guidelines, HIPAA and company standard operating procedures and policies.

Responsibilities:

Employee Management Responsibilities
  • Serve as supervisor and mentor to all direct reports as assigned.
  • Perform and/or oversee all HR responsibilities for site staff including but not limited to performance evaluations, corrective action plans, staff recognition, recruitment and onboarding of new employees, optimal conflict resolution, and management of staff schedules.
  • Provide access and/or resources for all employees to complete the training needed to perform job responsibilities.

Planning and Management
  • Work closely with the site head of Operations (e.g., Clinical Operations Manager, Director or Clinical Operations), develop and implement business plans for achieving the strategic and tactical goals and objectives of the site business.
  • Maintain Standard Operating Procedures, working guidelines, quality management plan, and associated training programs for the effective management of all aspects of clinical trial delivery, including but not limited to subject recruitment, appointment scheduling, vendor contracting, IRB approval and interactions, informed consent, subject visits, subject stipend delivery system, source document preparation, timely completion and entry of Case Report Form in EDC and Clinical Trial Management System.
  • Manage and motivate site staff to contractual and expected enrollment goals.
  • Ensure that all staff are adequately trained and adhere to Standard Operating Procedure and working guidelines.

Business Development
  • Participate in Business Development (BD) calls, and or other forums, to review the site's pipeline for planning purposes and to provide feedback.
  • Work with the BD team to complete feasibilities, expedite protocol reviews and "Go-No Go" decisions.
  • Evaluate study protocols (e.g., with respect to enrollment/retention potential, site capacity and capabilities, and other determinants of success), with input from the Principal Investigator, Recruitment Manager and Clinical Research team, as necessary for feasibility
  • Coordinate site visits and PI Meetings with sponsoring organizations and Clinical Research Staff; provide ongoing coordination of sponsor communications thereafter.
  • Interface proactively and collaboratively with centralized services (e.g., Quality Assurance, Central Recruiting, Business Development, etc.). Serve as primary point of contact at the site for ERG leadership.

Subject Recruitment
  • Oversee and coordinate plans for recruiting subjects into each study.
  • Responsible for proper implementation, expansion, and utilization of subject database.
  • Manage and motivate study teams to enrollment goals.
  • Participate in Community Outreach events as appropriate.

Quality Assurance and Regulatory Review and Management
  • Oversee the preparation and submission of regulatory materials to sponsors and oversight organizations.
  • Coordinate approval of materials developed or modified at site by sponsoring or managing organization, as required.
  • Coordinate approval of materials developed by site or sponsoring or managing organization by Institutional Review Boards (IRBs) and other outside regulatory organizations, as required.
  • Ensure that studies are implemented in compliance with Good Clinical Practice (GCP) guidelines as promulgated by the Food and Drug Administration (FDA) and the International Conference on Harmonization (ICH).
  • Design, implement, and / or oversee the ongoing Quality Assurance program for the site. Develop and maintain complete training files for all staff as outlined in the company's Standard Operating Procedures.

Study Operations
  • Contribute to effective management of all aspects of clinical research studies and related office operations.
  • Approve all hires and contractors in consultation with Human Resources and the Director of Operations / Clinical Operations Manager as needed.
  • Oversee Clinical Research Coordinators on training of all staff for study related procedures. of.
  • Coordinate the centralized support services (e.g., Accounting/Finance, Contracting, Business Development, Quality Assurance, etc..).
  • Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG's objectives.

Skills and Qualifications:
  • Education and experience
    • B.A. or B.S. required; advanced degree preferred.
    • Minimum of 3 years' experience in managing clinical trials.
    • Understand regulatory requirements, as well as Good Clinical Practices (GCP), HIPAA and International Conference on Harmonization (ICH) guidelines.
    • Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.
    • Knowledgeable in medical terminology to communicate with physician offices, pharmacists, and laboratory staff.
    • Able to manage a staff of clinical professionals and create a productive, satisfying work environment.
    • Demonstrate the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy.
  • Requirements
    • Excellent communication skills (interpersonal, written, verbal)
    • Ability to perform overnight business travel.
    • Good organizational and interpersonal skills
    • Attention to detail.
    • Excellent Computer Skills to include Word, Excel, PowerPoint, as well as proprietary applications unique to the clinical research industry (such as Study Manager)

About Linden Capital Partners

Linde plc is a global multinational chemical company founded in Germany and, since 2018, domiciled in Ireland and headquartered in the United Kingdom. Linde is the world's largest industrial gas company by market share and revenue. It serves customers in the healthcare, petroleum refining, manufacturing, food, beverage carbonation, fiber-optics, steel making, aerospace, material handling equipment, chemicals, electronics and water treatment industries. The company's primary business is the manufacturing and distribution of atmospheric gases, including oxygen, nitrogen, argon, rare gases, and process gases, including carbon dioxide, helium, hydrogen, ammonia, electronic gases, specialty gases, and acetylene. The company was formed by the 2018 merger of Linde AG of Germany and Praxair of the United States. The resulting holding company was incorporated in Ireland, with principal executive offices in Guildford, UK. The company is a member of the Hydrogen Council, a group of companies investing in hydrogen vehicles. The company expects hydrogen vehicles to compete with electric vehicles and has invested in wind powered plants that convert water to hydrogen. The company is ranked 444th on the Fortune Global 500 and 178th on the Forbes Global 2000.
Learn more about Linden Capital Partners
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Finance & Insurance
* Ladders Estimates

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