Clinical Project Manager II at ClinChoice

<p style="line-height: 1;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Clinical Project Manager II to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes.</span></p> <p style="line-height: 1;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">In this role, you will be responsible for the execution, oversight and delivery of clinical studies, including study tracking and management of vendor, site, and CRO activities. Candidates should have prior CRO experience and a strong background managing complex oncology and hematology clinical trials. This is a permanent remote opportunity with potential hybrid arrangement depending on location; our office is based in Horsham, Pennsylvania. Only candidates with previous CRO experience will be considered.&nbsp;</span></p> <p style="line-height: 1;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">Join our global team and help create a healthier world!</span></p> <p style="line-height: 1;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;"><strong>Main Job Tasks and Responsibilities:</strong></span></p> <ul> <li style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">Organizes and participates in Monitor’s and Investigator’s Meetings.</span></li> <li style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">Performs, if necessary, co-monitoring visits for the assigned clinical projects.</span></li> <li style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">Carries out, after appropriate and documented training/past experiences, the monitoring of the sites for the assigned projects, when requested and if applicable.</span></li> <li style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">May act as Feasibility Associate (FEA) after appropriate and documented training.</span></li> <li style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">Review and approve third party invoices for payment. Review and approve contractor timesheets for alliance with agreed scope of work.</span></li> <li style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">Develop and implement alternative solutions to problems with study timelines, resources, budgets, etc.</span></li> <li style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">Ensure issues are identified and communicated by the study team. Implement corrective action plan to prevent repetition of critical issues.</span></li> <li style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">Assess scope of work and timelines against contractual agreements and identify change orders pro-actively.</span></li> <li style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">Manage any deviations on resources and hours spent on the project to be able to evaluate the project progress and profitability and identify change orders in a timely manner and implement corrective actions. Ensure budget discrepancies are documented.</span></li> <li style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">Submit invoice requests, trial related invoices and payment authorizations to finance in a timely manner.</span></li> <li style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">Regularly track all expenditure and review for consistency with trial budgets.</span></li> <li style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">Organize quality check of filing of key study documentation.</span></li> <li style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">Ensure all administrative close-out procedures are completed.</span></li> <li style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">Follow and comply with the Company’s QMS, ISMS and PIMS requirements.</span></li> </ul> <p style="line-height: 1;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;"><strong>Education, Experience and Skills:</strong></span></p> <ul> <li style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">University Degree in scientific, medical or paramedical disciplines.</span></li> <li style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">Three (3) years (at least) of Project Management experience in the CRO/Pharmaceutical industry or six (6) years (at least) of experience as CM/CRA in a CRO/Pharmaceutical industry.</span></li> <li style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.</span></li> <li style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">Experience managing complex clinical studies-oncology and hematology required.</span></li> <li style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">Excellent English communication skills:written and verbal.</span></li> <li style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">Proficient in the use of computer software systems (Word, Excel, PowerPoint, Microsoft Project, Share Point, CTMS, timesheet software, EDC software, etc.).</span></li> <li style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">Ability to travel as required.</span></li> </ul> <p style="line-height: 1;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;"><strong>The Application Process</strong></span></p> <p style="line-height: 1;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.&nbsp; Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.</span></p> <p style="line-height: 1;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;"><strong>Who will you be working for?</strong></span></p> <p style="line-height: 1;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;"><strong>About ClinChoice&nbsp;&nbsp;&nbsp;&nbsp;</strong></span></p> <p style="line-height: 1;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!</span></p> <p style="line-height: 1;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;"><strong>Our Company Ethos</strong></span></p> <p style="line-height: 1;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.&nbsp;&nbsp; The success of these core values is evidenced by our below industry average turnover rates.</span></p> <p style="line-height: 1;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.</span></p> <p style="line-height: 1;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;"><strong>&nbsp;Key words:</strong> Project Manager, Clinical Project Manager, Senior Study Manager, Senior Clinical Trial Manager, Study Management, Project Management, Medical Devices, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Study Management, Project Leader, Project Lead, complex clinical trials, oncology, hematology, respiratory, CRO, Contract Research Organization, clinical trials, phase I-IV studies</span></p> <p style="line-height: 1;"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">#LI-VH1 #LI-PM II #LI-FULLTIME</span></p>