Senior Clinical Data Manager
4 일전에
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Why Fortrea?
Innovative Culture: Be part of a dynamic team that values creativity and fresh ideas.
Career Growth: Access continuous professional development opportunities to advance your career.
Work-Life Balance: Enjoy a flexible work schedule that lets you balance your professional and personal life.
Summary of Responsibilities:
• 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.
• 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.
• Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs.
• 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.
• 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.
• 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.
• 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).
• Coordinates the receipt and inventory of all data related information, from clinical sites and vendors as appropriate to meet timelines for deliverables. Ensure all appropriate documentation and procedures are performed upon project completion.
• Develop and maintain client relationships and review client satisfaction surveys. Implement appropriate action plans including driving process improvements and team training.
• 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.
• Provides leadership, mentorship, and coaching in DM related clinical trial processes, department technical capabilities, and associated turnaround durations to the internal study team.
• 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.
• Accountable for learning new DM technologies and applied processes, keeping up to date with industry wide technology and feasibility for process improvement at Fortrea.
• Ensures service and quality meet agreed upon specifications per the DMP and scope of work.
• Have input in writing, reviewing, and updating SOPs and associated documents as required.
• Maintain accurate records of all work undertaken.
• 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.
• Represent DM and where necessary overall Biometrics in new business opportunities.
• Attend and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team.
• Works with management team to develop and implement directional strategy by providing technical input into discussions and rolling out raining/mentorship to DM staff (as required).
• Actively promote Biometrics services to sponsors whenever possible.
• Performs other related duties as assigned by management.
• And all other duties as needed or assigned.
Experience (Minimum Required):
• +6 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.
• Thorough knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations.
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
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