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!
As Manager or Sr. Manager, Clinical Operations, you will be responsible for managing staff engaged in the clinical study conduct, including site selection and qualification, site initiation activities, site training, routine monitoring, audits, and payment process. You will collaborate with the internal Data Management group, internal Clinical Research group and any external vendors involved in study. You will be responsible for selection and management of Clinical Research Organizations and other consulting staff. You will provide support and leadership to members of a multidisciplinary project team throughout the conduct of assigned clinical trials under the guidance of the head of the Clinical Affairs department.
- Implement approved clinical trial protocols and operational plans, which are consistent with strategic corporate objectives.
- Assume primary accountability for the timely execution of those plans.
- Management of clinical study management staff (Clinical Study Managers, Field Monitoring Staff, Clinical Research Associates, Clinical Research Organization and Clinical Consultants and payment specialists).
- Developing and reviewing HIPAA disclosures
- Developing and reviewing informed consent materials and clinical trial recruiting materials.
- Participating in cross-functional assessments of all potential clinical studies
- Evaluation and disposition of Adverse Events, including managing the DSMB / CEC whenever applicable
- Participation in safety review activities, including recall activities to provide the clinical impact perspective
- Manage CTMS- related activities and interface with Data Management team
- Assist RA in preparation of responses to FDA deficiencies on pre-market and post-market submissions
- Manage workload in the Clinical Operations group and budget resources for new projects.
- Manage payment process to ensure compliant and timely invoice processing.
- Develop and monitor metrics for success of functions within group
- Generate SOPs and work instructions
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.
Required Skills, Knowledge and Abilities
- Project Management skills are required.
- Strong knowledge of ICH Guidelines on Good Clinical Practices (GCP), Food and Drug Administration (FDA) Code of Federal Regulation CFR 820., European Union Medical Device Directive and ISO 14155 standards on conduct of clinical trials on humans.
- This position has a strong customer focus on research sites, study site staff, physicians, and consultants. You position must possess strong interpersonal and leadership skills, promote teamwork and problem solving. You must be able to prepare and control study budgets and ensure timely invoice processing.
You will be responsible for completion of clinical activities identified via company’s needs assessment process, and will have freedom to operate within the assigned budget and personnel resources
Licensure, Registration and/or Certification
Certification in Clinical Research required or expected to be obtained within first three years of employment.
Required: Bachelor’s degree in a medical field and/or a Nursing degree
Preferred: Master’s degree in a medical or nursing field
Manager: minimum of 5 years of experience in clinical research
Sr. Manager: minimum of 8 years of experience in clinical research
For internal reference, the Manager is a level 8 and the Sr. Manager is a level 9.
**All candidates: Please completely fill out the online application and attach a resume that includes your current role, experience, education and contact information.**
Search Firm Representatives Please Read Carefully: MicroPort Orthopedics. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at MicroPort via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MicroPort. No fee will be paid in the event the candidate is hired by MicroPort as a result of the referral or through other means.
Job Type: Full-time
- 401(k) matching
- Dental insurance
- Employee assistance program
- Employee discount
- Flexible schedule
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Referral program
- Tuition reimbursement
- Vision insurance
- Day shift
- Monday to Friday
- Bonus pay
Ability to commute/relocate:
- Arlington, TN 38002: Reliably commute or planning to relocate before starting work (Preferred)
Work Location: One location