Manager, Global Clinical Monitoring (CRA Line Manager) at Precision Medicine Group

<p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">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.&nbsp;</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Due to our continued growth we are now seeking a Manager, Global Clinical Monitoring.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">As a Manager within our CRA Group, you will be responsible for leading, managing, and motivating a team of CRAs to a standard consistent with Precision for Medicine’s values and overall focus on quality.&nbsp; As well as oversight for CRAs, you will also be responsible for the career development of the organization’s Clinical Research Associate (CRA) workforce as well as supporting the development of departmental initiatives to strengthen the quality and productivity of operations within the group.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Essential functions of the job include but are not limited to: </span></p> <ul> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Generate action plans and provide developmental/strategic oversight to optimize CRA services, with a focus on high quality delivery of individual/team/departmental goals. </span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Assist with and contribute to project resourcing to ensure proper level and allocation resource is assigned for each project within their hierarchy (with respect to project phase). Update tracking systems and interface with project teams. </span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Collaborate with the Clinical Team Leads/Clinical Trial Managers and Clinical Operations Management Team to ensure that resource needs and site requirements are met appropriately. </span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Develop, mentor, manage and coach CRA staff to progress their skills so that Precision for Medicine quality standards are maintained. Advocate individual career development, and individual responsibility/accountability. </span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Perform accompanied site visits to assess CRA skills and developmental needs, as well as assist CRAs with project specific issues. </span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Identify quality risks and issues and recommend corrective action plans as needed to leadership team to address deficiencies in performance of employees. </span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Ensure that all staff have the proper resources, training, materials, and access to systems to deliver on the expectations of their position. </span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Ensure CRAs provide timely and accurate updates of all required administrative material (SOPs, T&amp;E, etc.) on company systems. </span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Work with the Clinical Operations Management Team to continually improve and enhance CRA expectations and procedures to promote quality, consistency and efficiency in execution. </span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Develop and maintain metrics pertinent to CRA resource oversight, and work with Clinical Operations Management Team on the evaluation of these metrics. </span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Participate in the interview process for new CRAs by conducting CV review and participating in the interviewing process. </span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Conduct on-boarding training for new CRA staff in conjunction with Human Resources, Clinical Training and other functional areas. </span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Represent Precision for Medicine in a professional manner • Manage CRA staff in accordance with Precision for Medicine’s values and policies. </span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Secondary responsibilities include assisting with the planning, assigning, and directing of work as well as gathering performance feedback to contribute to appropriate action plans. </span></li> </ul> <p><strong><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">The ideal candidate will have:</span></strong></p> <ul> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Graduate, postgraduate, 4-year college degree, or equivalent experience ideally in a scientific or healthcare discipline&nbsp;</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Extensive experience in clinical operations, data management or related discipline either in CRO or Pharmaceutical industry, with a minimum of 5 years onsite monitoring experience. </span><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Monitoring experience includes use of electronic data capture systems as well as paper and electronic medical records. </span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">3-5 years of direct supervisory experience managing CRAs&nbsp;</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Experience creating effective development programs for clinical staff. </span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Experience developing evaluation processes, performing gap analysis, and ensuring all clinical staff are properly trained to perform their duties consistent with Precision for Medicine quality standards&nbsp; </span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Ability to drive and availability for domestic and international travel including overnight stays, with an expectation of travel approximately 25%.&nbsp;</span></li> </ul> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.</span></p> <p>&nbsp;</p><div class="content-conclusion"><p>Any data provided as a part of this application will be stored in accordance with our <a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fprivacy-policy%2F&amp;data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&amp;sdata=9DgboiHTFPrNYVhdKhyfdwVyNYwUvZbP%2FroLdWIIfxw%3D&amp;reserved=0">Privacy Policy.</a>&nbsp;For CA applicants, please also refer to our&nbsp;<a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fca-applicants-privacy-notice%2F&amp;data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&amp;sdata=tfAqqMZsG%2B11IchL45HFFVbfECCkYqQpNr0PQxrMFJU%3D&amp;reserved=0">CA Privacy Notice</a>.</p> <p>Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.</p> <p>If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at&nbsp;<a href="mailto:[email protected]">[email protected]</a>.</p> <p>It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.</p></div>