Senior Clinical Data Manager,
Remote from anywhere in the U.S.
Get ahead in your career and make a difference in people’s
Are you a self-starter who knows how to take initiative in your
daily work? Would you enjoy making a real difference in the lives
If you are looking for a high-energy position in a collaborative
environment, learn more about the Lead Data Manager opportunity
with Covance by Labcorp
The Lead PDM leads and/or supports the
execution of data management activities necessary for the
generation of hypothesis and for decision making in research or
development phases, and for the preparation of submission data and
required documentation for regulatory authorities and the greater
clinical research community. May assume the business role of a
Study Data Manager in one or more clinical studies. In this
capacity, s/he serves as the primary contact for Data Management on
the Core Study Team. As an SDM, the Senior Clinical Data Manager
leads the DM team, which is comprised of several extended study
team members, to ensure data management deliverables meet, or
exceed, corporate and industry quality standards in a timely and
cost efficient manner. This includes the co-accountability with the
Statistics Lead to create, maintain and manage the Project Plan.
May also support research-driven activities, or support the
handling of data provided by highly specialized functions (e.g.,
Pharmacokinetic data, Biomarker data) ensuring data management best
practices, and the usability of the generated data in regulatory
The Lead PDM may also assume the role of a
key driver of medical standards implementation and maintenance at
the project level as well as ensuring a consistent standards
handling in the project’s studies. This critical responsibility is
necessary to ensure the project data is aligned with the Clinical
Development Plan. Ensures consistency across studies through close
interaction with the Clinical Project Team or Early Clinical Team,
mentoring/coaching of SDM(s) and overseeing the Data Management
- Serves as the key subject matter expert on topics related to data
management activities including specific activities and processes
in early clinical development phases. Contributions include, but
are not limited to: vendor selection and management, mentoring
junior staff, training team members, leading or contributing to
expert working groups (e.g., QSD initiatives), presenting best
practices at internal and external industry meetings
meetings/congresses, and participating in due diligence
The Lead PDM is responsible for the
consistency in support, planning and delivery of data management
deliverables in assigned studies, projects (if applicable), or
research activities. S/he is contributing to the development and
sharing of best DM practices. These efforts cascade throughout the
supported research and drug development value chain.
- Assumes operational and/or oversight responsibility as Study Data
Manager for all assigned internal and outsourced studies, and apply
Data Management best practices
- Accountable or a contributor for CDM
deliverables from protocol creation until release of data for
- Ensure CDM input and contributions to
Risk Management (risk identification, risk communication,
incorporation of risk in risk management plan, implementation of
risk mitigation activities in relevant plans)
- Incorporates and maintains Medical
Standards in clinical studies for all elements of the medical
- Documents all activities adequately for
all assigned studies according to SOPs and takes a lead role in QC
activities, which includes, but is not limited to: initiating the
documentation, maintaining document management systems,
coordinating and ensuring contributions from relevant functions,
requesting a timely QC of the documentation, informing relevant
functions of results and ensuring proper communication between
functions, QC manager and self so that all issues are
- Specifies and develops study specific
eCRFs, data consistency checks based on Medical Standards, the
Clinical Study Protocol and input from the study team.
- Prepares, tracks and implements standard
plans (i.e., Project Plan, Data Management Plan, Operational
Oversight Plan, etc.) to ensure proper governance of data
management study set-up, conduct and closure activities.
- Accountable for data management
activities necessary for the establishment of subject validity and
analysis set assignment, including but not limited to the
following: specification of important deviations and validity
findings, planning and conduct of interim and final Blind Review
Meeting, preparation and completion of the final Blind Review
Engages actively in ongoing data
review/reconciliation activities and utilizes dashboards, metrics
and patient trackers to
monitor data arrival and clean up. Shares data arrival and cleanup
status and metrics with the Study Team
- As applicable, plans and tracks data contributions of specialized
functions typically used for early clinical development activities
like Pharmacokinetics, Biomarker, Bioinformatics, Pharmacometrics,
as well as strategic operational partners.
- As applicable, establishes data
management best practices for data generated in relevant research
activities which may be needed in later project activities like
decision making processes and submissions. This includes but is not
limited to the following: support of setting data standards
compatible with development standards, support of central storage
and inventory, supporting data transfer activities from external
vendors, supporting integration with data generated in clinical
phases of development.
OPERATIONAL DATA MANAGEMENT
- Supports study data management and data cleaning processes on an
ongoing basis, applying study specific documents and
- Identifies and issue queries, incorporate
query replies and track query status.
- Contributes to projects and initiatives aimed at improving and
optimizing the delivery of DMAR, DS&A, Portfolio & Operations,
- Performs duties in compliance with SOPs, GCP and ICH guidelines
in accordance with regulatory, legal and ethical standards.
- Ensures complete, accurate and timely
documentation for all projects/studies according to established
- Represents CDM as the Core Study Team member for internal and
outsourced studies, and coordinates the DM Team in any aspect.
- Tracks and leads project-level data
management activities: manage PDM Teams/Early PDM Teams
efficiently; ensures the timely delivery of high-quality study
databases and smooth operation of SDM teams; identifies issues,
defines and directs resolution measures; reports progress and
escalate issues into management.
- Manages cross-functional team memberships
and interfaces effectively: closely aligns activities with
Statistics function applying the 2-Lead model principles, serves as
CDM member of the core Clinical Team or Early Clinical Team (as
- Works closely with clinical and safety
experts in the definition, preparation and review of reports that
are critical to ensuring the quality, accuracy and completeness of
analyses on study safety, medical coding and Pharmacovigilance
- Establishes and tracks data management
activities in co-operation with Pharmacokinetic department and
Pharmacometrics department, with internal research functions like
Biomarker and Bioinformatics, and with strategic external
- Develops robust and productive
relationships with internal and external business partners: treats
others fairly and with respect; manages conflicts constructively;
provides timely and relevant feedback.
Thrive personally and professionally as a Lead Project Data
You can bring your skills to the team and expect comprehensive
training so that you can continue to grow in your career. You will
serve as the technical leader on all projects and identify and
implement solutions for our clients in data management.
We also offer a competitive benefits package that takes care of
you. This includes medical and dental insurance as well as tuition
reimbursement, a 401(k) plan with a generous company match, PTO
days along with short and long-term disability and life
Why choose to work at Covance by Labcorp
• Make a direct impact in the lives of patients
• Become successful in the position with exceptional training
• Join a high-energy and team-driven workplace
• Open up new opportunities for career growth
What we’re looking for
Lead Data Managers are the most successful at Covance with:
• 6+ years of Clinical Data Management experience and at least 5
years of leading studies in a CRO setting. Combination of
CRO/Pharma is acceptable.
• Bachelor’s degree; additional relevant work experience considered
in lieu of degree.
• Full Experience including study start up, initiation, close out
• Demonstrated skill for technical management of studies with 5+
• Experience with Database Build; eCRF creation; UAT
• Demonstrated mentoring/delegation, communication and
Get to know Covance by Labcorp
At Covance, we value your unique point of view and bold ideas to
advance modern healthcare. Join our team and see how our
collaborative work environment along with mentoring, training and
career development can help you be successful at work and in your
Together, let’s shape new possibilities for your career and advance
healthcare around the world.
Covance by Labcorp is an equal opportunity employer and will not
discriminate against any employee or applicant for employment
because of race, color, religion, sex, sexual orientation, gender
identity, national origin, disability, or veteran status.
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 technology).
relevant work experience will be considered in lieu of formal
knowledge of drug development processes.
of global clinical development budgets and relationship to
of effective clinical data management practices.
of time and cost estimate development and pricing
knowledge of ICH Guidelines and GCP including international
regulatory requirements for the conduct of clinical development
programs, especially as related to data handling and
five (5) years relevant work experience in clinical data management
and 5 years of clinical data lead experience in Pharma and or CRO
of 3 years of onoclogy experience required.
management of gross revenues
oral and written communication and presentation skills.
depth knowledge of clinical trial process and data management,
clinical operations, biometrics, quality management, and systems
applications to support operations.
knowledge of the relationship and regulatory obligation of the CRO
industry with pharmaceutical / biotechnological
to lead by example teams on project strategies and achievement of
department goals, objectives, and initiatives and to encourage team
members to seek solutions.
managerial and interpersonal skills