Senior Clinical Data Manager-Remote
Posted on: March 17, 2023
The Senior Clinical Data Manager leads 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.What to Expect
- Ability to organize and effectively prioritize workload and
- 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
- 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
- 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,
- 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
- 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.Education/Qualifications
- 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
- 5 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
- Thorough knowledge of clinical trial process, DM, clinical
operations, biometrics, and system applications to support
- 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
- Time management skill and ability to adhere to project
productivity metrics and timelines.
- Ability to work in a team environment and collaborate with
- 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
- Constructive problem-solving attitude while deadline focused
with time demands, incomplete information or unexpected events.US
Pay Range:--$70,000-$130,000Benefits: All job offers will
be---based on a candidate's skills and prior relevant experience,
applicable---degrees/certifications,---as well as internal equity
and market data.---Regular, full-time or part-time employees
working 20 or more hours per week are eligible for comprehensive
benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K),
ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus
where applicable.-- For more detailed information, please
As a leading contract research organization (CRO), Labcorp Drug
Development provides comprehensive drug development solutions for a
range of industries. Our services cover the preclinical, clinical
and post-market phases of drug development, the product life cycles
for medical device and diagnostics and development services paired
with regulatory support for the chemical testing and crop
Labcorp Drug Development is a global leader in nonclinical safety
assessment, clinical trial testing and clinical trial management
services. Our unique perspectives are based on decades of
scientific, medical and regulatory expertise.
In July 2022, Labcorp announced its intention to spin off its
clinical development business as a separate public company, subject
to the satisfaction of certain customary conditions. Fortrea will
become the new brand identity for our Clinical Development business
in connection with the spin-off, which is expected in mid-2023.
We believe that the exceptional is possible when you have the right
partner, so we are looking for the right people to help build a
transformative force in Clinical Development. Labcorp is proud to
be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion
in the workforce and does not tolerate harassment or discrimination
of any kind. We make employment decisions based on the needs of our
business and the qualifications of the individual and do not
discriminate based upon race, religion, color, national origin,
gender (including pregnancy or other medical conditions/needs),
family or parental status, marital, civil union or domestic
partnership status, sexual orientation, gender identity, gender
expression, personal appearance, age, veteran status, disability,
genetic information, or any other legally protected characteristic.
We encourage all to apply.
For more information about how we collect and store your personal
data, please see our--.--
Keywords: LabCorp, Burlington , Senior Clinical Data Manager-Remote, Executive , Burlington, North Carolina
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