POSITION SUMMARY

Under the direction of the Director of Clinical Research, the Clinical Study Manager is responsible for managing and monitoring of the Medacta USA (MUSA) routine clinical trial activities. The role is responsible for ensuring that MUSA's clinical research activities are performed to the highest quality and ethical standards. The position will require flexibility and the ability to work both independently and in a small team environment.

QUALIFICATIONS

Educational Requirements:

Bachelor's Degree in a related healthcare discipline. Clinical research experience in lieu of a degree shall be considered. Certified clinical research professional preferred. Knowledge of IRB policies, ICH GCP guidelines, FDA regulations.

Experience Requirements

5+ years of clinical research experience, clinical monitoring and study experience preferred.

Required Skills and Abilities:

• Experience with study and site level management of clinical trials, including but not limited monitoring clinical trials.
• Ability to work independently, including off-site travel.
• Strong computer skills, including prior experience with clinical research data systems.
• Ability to maintain tact, poise, and discretion in handling confidential matters.
• Highly organized and detail oriented. Ability to analyze and solve problems.
• Ability to handle multiple tasks concurrently. Excellent time management skills.
• Physical Requirements

• • Sitting: Extended periods at a desk or workstation.
  • Standing and Walking: Frequent movement within the office.
  • Lifting and Carrying: Light to moderate lifting of office materials, supplies, etc.

Additional tasks may require reaching, manual dexterity, and visual acuity.

INTERPERSONAL CONTACTS

External: Medical professionals, surgeons, nurses, clinical study professionals, clinical research related vendors

Internal: Marketing, Research and development, Clinical Research

Travel requirements: 50-70%

Extent of Confidential Information: This position occasionally will encounter confidential information which will be treated according to the company policy to ensure all information is protected.

Reporting: Clinical updates to internal colleagues

PRINCIPAL DUTIES

• Oversee and/or contributes to the preparation of clinical documents, e.g., protocols, investigator brochure, annual report updates, case report forms and clinical study reports, monitoring plans, and budgets.
• Maintains and manages all aspects of studies including protocol, CRF and database development, site recruitment, budget and agreement negotiation, study initiation, trial maintenance, data monitoring, data reporting, trial master file maintenance, and product and payment tracking.
• Utilizes communications, reports, EDC systems to proactively identify potential barriers to project completion and data integrity and proactively implements effective strategies to correct/avoid such barriers.
• Demonstrates problem-solving strategies and develops alternative solutions and contingencies to address issues as they occur; instills a practice of continuous improvement with team.
• Drafts/updates, reviews standard operating procedures, work instructions, and controlled forms
• Develops and implements training plans for sites, ensuring skills and certifications are timely relative to assigned projects.

• Perform monitoring and/or auditing of investigative sites, CROs, and MUSA study files.
• Ensure site compliance while conducting qualifications, study initiation, routine monitoring, and study site close-out visits for research sites according to Medacta's Standard Operating Procedures (SOPs);
• Provide training and guidance to Principal Investigator and site staff regarding compliance with research regulations and guidelines, the clinical protocol, and data collection requirements.
• Assist in reporting and follow-up of clinical unexpected and Serious Adverse Event (SAE) reporting.
• Ensure all critical documents related to clinical trials are organized and maintained in audit-ready condition.
• Monitor (as needed) study investigational product, supply inventory, and destruction according to SOPs and regulations.
• Conduct travel according to company policy, which is expected to be between 30-50% (or may be less due to virtual site monitoring) yet may fluctuate depending on project needs.

OCCASIONAL DUTIES

Other duties may be assigned at Medacta USA's discretion.