Clinical Study Manager I or II

MicroPort Orthopedics

Posted on: May 12, 2022

Closing: June 11, 2022

Salary: Undisclosed

Position Type: Full Time

Job Description

At MicroPort Orthopedics, we are never standing still. We know that knee and hip implants are constantly being improved just as medical procedures themselves evolve with each passing day. We not only embrace this constant advance in medicine. We celebrate it in our work. We operate with the heart of a start-up but the soul of an industry powerhouse. This is critical to achieving our goal of being the fastest growing, innovation driven company in orthopedics. Our top priority isn’t just to help surgeons get patients back on their feet. We want to help patients get back to Full Function, Faster. Come be a part of the journey!

Overall Purpose

As Clinical Study Manager I or II, you will be responsible for providing project management and leadership to plan, prepare and execute one (or more) clinical project(s). You will internally interface with data management, clinical research associates, Quality, Regulatory, and functional management. You will act as liaison with external customers including site investigators, clinical site staff, and medical and scientific personnel. As Clinical Study Manager I or II, you will be accountable for timeline development, communication, and accountability of study outcomes and milestones to internal and external customers.

Skills Requirements

  • Solid understanding of the clinical study process, preferably of medical devices.
  • Proficient working knowledge of the regulations (Food and Drug Administration (FDA), Good Clinical Practice (GCP), International Committee on Harmonization (ICH), ISO, etc).
  • Organizational awareness to operate in cross-functional teams and provide leadership to other clinical staff members.
  • Effective communication and time management skills required.
  • Must commit to work in a safe environment that is quality- and customer-focused.
  • Must recognize and commit to a sense of urgency, teamwork.
  • Must be able to take and maintain initiative.
  • Possess strong interpersonal skills with the ability to interact with peers, medical professionals, consultants, and Regulatory Agencies as required.
  • Must be able to plan, problem solve with the use of critical thinking skills.

Principal Responsibilities

Clinical Study Manager I

  1. Design, implement, manage, and terminate clinical studies.
  2. Manage clinical studies and ensure they are carried out in accordance with the Protocols, Good Clinical Practices (GCP's), Standard Operating Procedures (SOP's) and other regulatory requirements.
  3. Collaborate in the development, approval, and distribution of study-related documents including study protocols, informed consent documents, case report forms, study plans, study manuals, training materials, and other study tools to investigational sites and review committees.
  4. Must have the ability to monitor on-going compliance to study protocols and site adherence to global regulatory guidelines.
  5. Prepare and participate in presentation of protocols and other study requirements at study initiations at investigational sites when needed.
  6. Manage the distribution, collection and tracking of regulatory documentation to ensure compliance at both the sites and Sponsor Central File, and for audit readiness.
  7. Track and report progress of studies including patient enrollment/screening, patient accountability, device accountability, etc.
  8. Work with Data Management as needed to ensure proper data is provided for their input analysis and output of reports.
  9. Prepare and provide timely reports to management.
  10. Assist in the development and management of study budget.
  11. Maintain registrations on Clinical trial.gov.
  12. Review Monitoring Trip Reports provided by Field Monitors.
  13. Select and qualify clinical trial investigational sites, including managing aspects related to physician relationships, and manage IRB/EC approvals (initial and ongoing).
  14. Participate in the development and implementation of internal policies & procedures to optimize management of clinical trials; contribute to process improvement.
  15. Oversee and participate, as needed, in site close-out visits, report reviews, and follow-up to resolve final site issues.
  16. Work with Regulatory Affairs as needed to provide accurate and timely reports, such as annual reports or safety reports to the FDA and other regulatory bodies.

Clinical Study Manager II

  1. Design, implement, manage, and terminate clinical trials.
  2. Manage clinical studies and ensure they are carried out in accordance with the Protocols, Good Clinical Practices (GCP's), Standard Operating Procedures (SOP's) and other regulatory requirements.
  3. Collaborate in the development, approval, and distribution of study-related documents including study protocols, informed consent documents, study plans, study manuals, and other study tools to investigational sites and review committees.
  4. Prepare and participate in presentation of protocols and other study requirements at study initiations at investigational sites when needed.
  5. Must have the ability to monitor on-going compliance to study protocols and site adherence to global regulatory guidelines.
  6. Oversee subject screening and enrollment at assigned clinical sites, track enrollment.
  7. Manage the distribution, collection and tracking of regulatory documentation to ensure compliance at both the sites and Sponsor Central File, and for audit readiness.
  8. Assist in the planning, preparing, and distributing of materials for investigator and coordinator meetings, and for study related training.
  9. Track and report progress of studies including patient enrollment/screening, patient accountability, device accountability, etc.
  10. Management of various clinical study contractors including selected contract research organization (CRO) staff and contract monitors (domestic and international)
  11. Provide mentoring to junior staff regarding protocols and site management.
  12. Assist data management with the development and review of Case Report Forms for content and ensure proper data is provided for their input analysis and output of reports.
  13. Prepare and provide timely reports to management.
  14. Develop clinical site training and education and site binders.
  15. Maintain registrations on Clinical trial.gov.
  16. Review Monitoring Trip Reports provided by Field Monitors.
  17. Select and qualify clinical trial investigational sites, including managing aspects related to physician relationships, and manage IRB/EC approvals (initial and ongoing).
  18. Assist in the distribution of investigational product.
  19. Participate in the development and implementation of internal policies & procedures to optimize management of clinical trials; contribute to process improvement.
  20. Oversee and participate, as needed, in site close-out visits, report reviews, and follow-up to resolve final site issues.
  21. Work with Regulatory Affairs as needed to provide accurate and timely reports, such as annual reports or safety reports to the FDA and other regulatory bodies.

Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

 

Compliance

Ensure all clinical studies are developed, initiated, and carried out in a compliant manner from initiation to termination. Adhere to the AdvaMed Code of Ethics on Interactions with Health Care Professionals and any related ethical, compliant business practice including, but not limited to, compliance with the Company’s Compliance Program, FDA regulations and guidance, Anti-Kickback Statute, and other Federal, state and/or local laws. Complete the required compliance training successfully and on-time.

Accountability

  • Ability to work autonomously with some supervision
  • Ability to assist in departmental meetings
  • Must stay abreast of current research practice
  • Provide project evaluation and updates as needed for departmental decisions
  • Must be able to prioritize in order to meet deadlines
  • Ability to organize and efficiently manage workload assignments
  • Must demonstrate effective interaction with internal and external customers
  • Must present and maintain overall professionalism
  • Ability to collaborate and lead other clinical team members with a sense of urgency as needed in order to meet deadlines and goals

Experience Requirements

I: Minimum 3 years of previous clinical research experience required

II: Minimum 5 years of previous clinical research experience required

Education Requirements

B.A./B.S. in Health Science related field or equivalent (i.e. RN in Nursing, etc.)
Certification in Clinical Research preferred

MicroPort Orthopedics

Posted on: May 12, 2022

Closing: June 11, 2022

Salary($): Undisclosed

Position Type: Full Time

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