Medical Data Review Specialist II/ Associate Manager/ Manager

<h2>Job Overview:</h2><ul><li style="color: #000000;"><span style="font-size: 10pt; font-family: verdana, geneva;">Collaborates in the development of Central Monitoring proposal text and review of costing, contributes to proposal strategy and development when Central Medical Review is included</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Support Sponsor presentations / bid defenses.   </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Ensures that tracking and status reporting are performed in a timely and accurate manner. </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Applies data to recommend any patient safety concerns</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Identify and evaluate safety signals based on individual cases and cumulative data assessment and by using other signal detection systems.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Contributes to the Risk Assessment and Categorization Tool for topics related to medical review and considers risks when planning Xcellerate® Medical Review configuration</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Supports the Data Expert with Critical Data and Process Definition and EDC design implementation   </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Supports the development of medical review requirements, including design of the visualizations, taking into consideration the data feeds for the study (EDC, laboratory, etc.).</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Drafts and finalizes the Central Medical Review Configuration Plan. Maintains this Plan throughout the study including re-versioning as required.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Drafts Central Monitoring /Central Medical Review Plans in collaboration with the Central Monitoring Manager (if applicable) and Project Physician and updates these on an ongoing basis including the refinement of visualizations and any change in data</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Manages configuration of Xcellerate® Medical Review (XMR) tool, programming of study specific visualizations included in XMR and performs user acceptance testing of the tool</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Performs ongoing Central Medical Review, discusses findings with Project Physician (internal and/or client) and ensures that identified issues are followed to resolution, and where required, that a report is written.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">May act as subject matter expert based on education qualification/experience.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Provide data-driven decisions and communicate these findings proactively and effectively to the key stakeholders.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Take responsibility for inspection readiness for medical assessment activities; support regulatory authority inspections when needed.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Collaborates with other Central Monitoring activities to ensure consistency and effectiveness.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Evaluates and collates process improvement suggestions and submits to leadership.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Evaluates and submits ideas and justification for improved systems and tools to leadership.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Provide training on the project and process to new team members.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Mentoring of new team members.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Line management of Medical Reviewers, if assigned</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Support department leadership with work assignments and coordination of work</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Develop client specific processes if needed</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Any other duties assigned by supervisor.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: verdana, geneva; font-size: 10pt;"><strong>If acts as line manager, the following responsibilities apply.</strong> </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Assign and classify tasks to the First Line managerial staffs or employees</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Supervise, Mentor and evaluate performance of staff to ensure career development, interpersonal skills and achievement of Competency standards.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Looking after the work force’s HR needs</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">In Collaboration with first line level manager, assist in recruitment of new staff to MDR/CM.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Budgeting and scheduling for work force required to perform tasks</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Ensure the smooth functioning of Central Monitoring department in the organization</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Responsible for managing Performance review and issues of direct reports.</span></li></ul><h2>Education/Qualifications:</h2><p style="margin: 0in 0in 0pt;"><span style="font-size: 11pt;">Medical doctors with <strong>3-10 years</strong> of experience in medical practice/equivalent clinical research roles or Para professionals and Life science graduates with <strong>2-14 years</strong> of clinical research/equivalent experience</span>,<span style="font-size: 11pt;"> e.g. clinical monitoring, data management, Medical Data review, informatics etc.</span></p><h2>Experience:</h2><ul><li><span style="font-size: 11pt;">Medical Doctors, Allied medical degrees, Post-graduation in Life sciences or any other applicable qualifications</span></li><li><span style="font-size: 11pt;">Willingness to work in shift based environment (specific 2:30 PM to 11:30 PM)</span></li></ul>