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 in order 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.
University / college degree (life sciences, health sciences, information technology or related subjects preferred).
Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor's degree.
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.
Thorough knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations.
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.
Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies.
Time management skill and ability to adhere to project productivity metrics and timelines.
Ability to work in a team environment and collaborate with peers.
Ability to mentor junior members of the department, providing SME guidance on DM practices,
Experience of representing DM in bid defense meetings, providing innovative solutions to meet client needs.
Good organizational ability, communication, and interpersonal skills.
Constructive problem-solving attitude while deadline focused with time demands, incomplete information or unexpected events.