Senior Clinical Data Manager - Remote within United States or Canada

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Labcorp Drug Development has an exciting opportunity for a Senior Clinical Data Manager. The Senior Clinical Data Manager can be remotely located anywhere within the United States or Canada. </span></p><p style="margin: 0px;"> </p><ul><li style="color: windowtext;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Lead studies including (but not limited to) a combination of healthy volunteer and patient populations, multi-site, complex protocol design, strong client management required or reduced timelines. Ability to organize and effectively prioritize workload and deliverables.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">As the Study Manager, be accountable for all DM deliverables as assigned per the established timeline; providing instruction to their DM study team(s) and review of their study team’s output to ensure the highest quality, while adjusting resource allocations accordingly. </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs. </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Work with the Project Manager(s) or FSP Lead (or designee) to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team as necessary, including at study initiation meetings. </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Provide DM project team leadership and accountability; leads data focused internal project team meetings; meets frequently with the study leads of EDC Design, SAS Programming, Statistics, and PK to ensure that all deliverables are planned and coordinated intradepartmental; proactively identifies potential risks/mitigations, effectively communicates data-driven discussions in order to achieve database lock dates; keeps the Project Manager or FSP Lead (or designee) apprised of project progress. </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Maintain awareness of other Biometrics functional group deliverables to be able to support risk and mitigation strategies, including impact on DM resources or deliverables and consult with Project Manager (or designee) and/or functional group management as necessary. </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Keep Project Manager (or designee), Biometrics management team and/or sponsor services informed of pertinent project or sponsor related information (i.e. budget status, work scope changes, timeline impacts). </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Coordinates the receipt and inventory of all data related information, from clinical sites and vendors as appropriate in order to meet timelines for deliverables. Ensure all appropriate documentation and procedures are performed upon project completion. </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Develop and maintain client relationships and review client satisfaction surveys. Implement appropriate action plans including driving process improvements and team training. </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Track scope changes and work with the Project Manager or FSP Lead (or designee) to ensure that Sponsor approval is received, and the scope change processed. </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Provides leadership, mentorship, and coaching in DM related clinical trial processes, department technical capabilities, and associated turnaround durations to the internal study team.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Provide support to DM supervisors and managers on the performance evaluation of other team members, provide constructive feedback to aid in career development, interpersonal skills and achievement of competency standards. </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Accountable for learning new DM technologies and applied processes, keeping up to date with industry wide technology and feasibility for process improvement at Labcorp Drug Development. </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ensures service and quality meet agreed upon specifications per the DMP and scope of work. </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Have input in writing, reviewing, and updating SOPs and associated documents as required. </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Maintain accurate records of all work undertaken. </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Perform reconciliation of the clinical database against safety data, laboratory data or any other third-party data as appropriate. Utilize local laboratory systems and batch data load facilities where appropriate. </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Represent DM and where necessary overall Biometrics in new business opportunities. </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Attend and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team. </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Works with management team to develop and implement directional strategy by providing technical input into discussions and rolling out training/mentorship to DM staff (as required). </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Actively promote Biometrics services to sponsors whenever possible. </span></li><li style="color: #000000; font-family: Times New Roman; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Performs other related duties as assigned by management.</span></li></ul><h2>Education/Qualifications:</h2><ul><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">University / college degree (life sciences, health sciences, information technology or related subjects preferred). </span></li></ul><ul><li style="color: black; font-family: 'Calibri',sans-serif; font-size: 12pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor’s degree. </span></li></ul><h2>Experience:</h2><p style="margin: 0in 0in 0pt -0.25pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Minimum Required: </strong></span></p><ul><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">8 years of combined early or late-stage DM experience with minimum 2 years of direct sponsor management and at least 2 years technical mentoring experience. Proven experience in handling customer negotiations and experience with managing Scope of Work and budgets. </span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Thorough knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations. </span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Proven ability to lead by example on project strategies and achievement of department goals, objectives and initiatives and to encourage team members to seek solutions. </span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies. </span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Time management skill and ability to adhere to project productivity metrics and timelines. </span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ability to work in a team environment and collaborate with peers. </span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ability to mentor junior members of the department, providing SME guidance on DM practices, </span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Experience of representing DM in bid defense meetings, providing innovative solutions to meet client needs. </span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Good organizational ability, communication, and interpersonal skills, </span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Constructive problem-solving attitude while deadline focused with time demands, incomplete information or unexpected events. </span></li></ul><p style="margin: 0in 0in 0pt 0.25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"> </span></p><p style="margin: 0in 0in 0pt -0.25pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Preferred<strong>: </strong></span></p><ul><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Through knowledge of Labcorp Drug Development, the overall structure of the organization and Standard Operating Procedures (SOPs). </span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Four or more years of Electronic Data Capture experience.</span></li></ul><p style="margin: 0px;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">#LI-REMOTE</span></p>