Drug Development is seeking candidates for a Clinical Data Manager
II-BioM. The Clinical Data Manager II-BioM will be remotely
(home-based) located anywhere within the United States or
Management leadership for all aspects of the data management
process to include responsibility for the development of the
project documentation, system set-up, data entry and data
validation procedures and processes assigned to more junior staff.
Also assume responsibility for all data management activities
leading to database lock according to Client quality expectations
within project timelines and budgets.
data focused project team meetings, meeting frequently with the
study leads of Electronic Data Capture (EDC) Design, SAS
Programming, Statistics, and PK to ensure that all deliverables are
planned, coordinated interdepartmentally, and proactively
identifying potential risks and mitigations, and effectively
communicating data-driven discussions in order to achieve database
lock dates with the highest possible data quality.
Essential Job Duties:
Lead study Data Manager for studies which are medium complexity
including but not limited to - combination of healthy and patient
populations, multi-site, medium complexity in protocol design or
client management requirements.
the study data lead; be accountable for all DM deliverables per the
established timeline; providing instruction to their DM study
team(s) and review of their study team’s output to ensure the
highest delivery 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) 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
apprised of project progress.
Maintain awareness of other Biometrics functional group
deliverables to be able to support risk and mitigation strategies,
including impact on Data Management resources or deliverables and
consult with Project Manager and/or functional group management as
Keep Project Manager, Biometrics management team and/or sponsor
services informed of pertinent project or sponsor related
information (i.e. 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
Ensures study specific Data Transfer Agreements are put in place
for all ancillary data vendors involved in the study.
Develop and maintain client relationships and review client
satisfaction surveys. Implement appropriate action plans including
driving process improvements and team training.
Applies corrective interventions where necessary to maintain
project budget compliance and profit expectations. Track scope
changes and work with the Clinical Pharmacology Project Manager to
ensure that Sponsor approval is received and the scope change
Provides leadership, mentorship, and coaching in DM related
clinical trial processes, department technical capabilities, and
associated turnaround durations.
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.
Performs QC on all aspects of work performed in DM to ensure that
data quality and integrity is maintained. Feedback constructively
on relevant issues and initiate process review as
Maintain accurate records of all work undertaken.
Perform quality control on all aspects of the study as appropriate
to include, but not be limited to: all study documentation, query
generation and integration; to ensure that internal and client
quality standards are achieved.
Perform reconciliation of the clinical database against safety
data, laboratory data or any other third party data as appropriate.
Utilise local laboratory systems and batch data load facilities
Perform medical and medication coding
Oversee the performance of the Data Management Study team to ensure
that client satisfaction is achieved through delivery of quality
data, on-time and on-budget. Arrange internal or external meetings
Attend and action client or internal audits as appropriate and
resolve all issues within an appropriate timeframe. Address client
comments with the study team.
Actively promote Biometrics services to sponsors whenever
Performs other related duties as assigned by management.
University/college degree (life science, pharmacy or related
subject preferred), or certification in a related allied health
profession from an appropriately accredited institution (e.g.,
nursing certification, medical or laboratory
Knowledge of drug development process.
Knowledge of effective clinical data management
Fluent in English, both written and verbal.
lieu of above requirement, approximately six years experience in
related field (e.g. pharmaceutical, laboratory, data
Knowledge of Labcorp Drug Development and the overall structure of
Knowledge of Labcorp Drug Development standard operating
to six years of combined early or late stage DM experience in DM
with up to two years of direct sponsor management and two years of
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
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
Good organizational ability, communication and interpersonal
Team working skills and good collaborator skills.
Constructive problem solving attitude while deadline focused with
time demands, incomplete information or unexpected
Knowledge of medical terminology.
Knowledge of science or a scientific background is
Good oral and written communication skills.
Through knowledge of Labcorp Drug Development, the overall
structure of the organization and Standard Operating Procedures
Four or more years of Electronic Data Capture
Experience as a hands on Data Manager with capability of leading
and driving all study related deliverables to ensure client
expectations are being met in a timely manner and within