Associate Director, Clinical Operations/Country Manager

<p><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. </span></p> <p><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Due to our continued growth we are seeking a<strong> Associate Director, Clinical Operations/Country Manager</strong> to be based in South Korea.</span></p> <p><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">The Associate Director, Clinical Operations/Country Manager, provides leadership to the Clinical Operations Department (Clinical Trial Management/Clinical Monitoring). This role ensures the delivery of high quality, timely and cost-effective clinical trial operations in compliance with ICH-GCP, Federal regulations, SOPs and other applicable regulations.  The Associate Director collaborates with executive management on the ongoing development of the Clinical Operations Department and contributes to the business plan at both the tactical and strategic levels.</span></p> <p><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Essential functions of the job include but are not limited to: </span></p> <ul> <li style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Contributes to the development and revision of Clinical SOPs and department guidelines to ensure adherence to applicable ethical, regulatory and clinical standards.</span></li> <li style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Ensures CRA resources and other Clinical project resources are continuously adequate; interviews and selects CRAs for studies.</span></li> <li style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Coordinates the activities of employees and contract Clinical Operations team members; designates site assignments, tracks and reviews monitoring reports and calendars. Assists in the resolution of employee and contract CRA performance issues, including termination of contracts as needed.</span></li> <li style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Represents Clinical Operations on company-wide project teams.</span></li> <li style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Assists with the Clinical Operations and Project Team Meetings, including development of meeting agendas and minutes.</span></li> <li style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Produces periodic reports.</span></li> <li style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Provides input regarding Clinical Operations for proposals, budgets and contracts; participates in bid defense meetings.</span></li> <li style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">May participate in the analysis and development of Clinical Operations and Project Management department budgets.</span></li> <li style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Hires and trains Clinical Operations employees.</span></li> <li style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Development of department job descriptions.</span></li> <li style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Adheres to applicable ethical, regulatory and clinical standards.</span></li> <li style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">May perform other duties as assigned.</span></li> <li style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Follow applicable regulations, including FDA, ICH, and Agility Clinical Policies and Procedures.</span></li> </ul> <p><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Project Related Responsibilities:</span></p> <ul> <li style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Primary interface with Client representatives as well as Agility Clinical (Agility) personnel in the Project Management, Data Management, Medical and Safety, and Biostatistics departments to ensure the timely initiation and completion of clinical trials.</span></li> <li style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Ensures standards for monitoring and reporting are met.</span></li> <li style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Coordinates study specific training and other requirements for internal and external staff, as appropriate.</span></li> <li style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Assigned to manage full-service, large-scale, complex projects.</span></li> </ul> <p><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"> </span></p> <p><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Qualifications:</span></p> <p><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Minimum Required:</span></p> <ul> <li style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Bachelor’s degree in a clinical, scientific, or related field, or equivalent work experience required </span></li> <li style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-