Clinical Study Manager

Medacta® is a Swiss-based orthopedic company founded in 1999, renowned for its innovative products and surgical techniques. Notably, they pioneered the Anterior Minimally Invasive Surgery (AMIS®) technique for hip replacements, leading to minimally invasive approaches. Leveraging their extensive orthopedic expertise, Medacta introduced MySolutions technology, which provides surgeons with highly personalized pre-operative planning and implant placement methodologies. Utilizing advanced personalized kinematic models and 3D planning tools, MySolutions enhances surgical precision in hip, knee, shoulder, and spine procedures. Medacta's blend of orthopedic expertise and cutting-edge technology drives continual advancements in the field, enhancing patient care worldwide.

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 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. We invite you to complete the optional self-identification questions below used for compliance with government regulations and record-keeping guidelines. Any self-identification information provided will not be considered in the selection process. GENDER Male Female Nonbinary I do not wish to self-identify my gender ETHNICITY American Indian/Alaska Native (Not Hispanic or Latino) Asian (Not Hispanic or Latino) Black/African American (Not Hispanic or Latino) Hispanic/Latino Native Hawaiian/Other Pac Island (Not Hispanic or Latino) White (Not Hispanic or Latino) Two or More Races (Not Hispanic or Latino) Decline to Specify If you believe you belong to any of the categories of protected veterans listed below, please indicate by selecting the appropriate category(ies). The hiring employer is subject to the Vietnam Era Veterans' Readjustment Assistance Act of 1974, as amended by the Jobs for Veterans Act of 2002, 38 U.S.C. 4212 (VEVRAA) and requests this information in order to measure the effectiveness of the outreach and positive recruitment efforts it undertakes pursuant to VEVRAA. Disabled Veteran Armed Forces Service Medal Veteran Veteran who served on active duty during a war or in a campaign or expedition for which a campaign badge has been authorized Recently Separated Veteran Veteran, but not one of the four protected classes above I decline to state my veteran status Not a Veteran We are required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years. Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at Yes, I Have A Disability, Or Have A History/Record Of Having A Disability No, I Don’t Have A Disability, Or A History/Record Of Having A Disability I Don’t Wish To Answer #J-18808-Ljbffr Valid8 Financial, Inc.