Lead Clinical Data Manager
Company: Emergent BioSolutions
Location: Redwood City
Posted on: October 14, 2020
Those who join Emergent BioSolutions feel a sense of ownership
about their future. You will excel in an environment characterized
by respect, innovation and growth opportunities. Here, you will
join passionate professionals who advance their scientific,
technical and professional skills to develop products designed-to
The Lead Clinical Data Manager position is responsible for the
technical and administrative functions associated with a clinical
trial. The primary responsibilities include EDC set-up, study
database design, data discrepancy management, data review, project
support, and study document management. The position will perform
duties in compliance with the protocol, data standards, and
Reasonable accommodations will be made to enable individuals with
disabilities to perform the essential functions.
* Lead the design of CRFs, CRF completion guidelines, and data
* In close collaboration with the clinical study team, develops
logic and/or reviews edit check specifications; programs and
validates and/or validates edit checks to facilitate cleaning of
* Responsible for database design, programming and validation, and
maintenance for clinical study databases with a focus on accurate
data collection and compliance with data standards and SOPs.
* Coordinate and perform successful conduct of user acceptance
testing with participation of Clinical and Biostatistics team
* Assist in the creation, review, and oversight of document such as
Data Management Plans, eCRF completion guidelines, and source
documents for completeness and consistency
* Manage of external data specifications (such as laboratory or EKG
data specifications) in consultation with Clinical Operations and
* Lead review of EDC data for completeness and correctness,
querying of sites for problems, issues, or trends and escalation
within Clinical Development as necessary. Reconciliation of
external data (such as laboratory data, serious adverse
events/events of interest information, or, if needed, independent
review by medical personnel) with EDC data
* Perform basic medical coding activities and liaise with Medical
Monitor for coding approval. Collaborate with Pharmacovigilance
department to perform serious adverse events reconciliation.
* Interact with clinical study team members to resolve database
issues and report on the progress of CDM activities. Represent data
management on clinical study teams.
* Use and develop data views for optimal and efficient review of
large quantities of data.
* Leads regular data review activities with the clinical team to
ensure accuracy, consistency and reliability of data; may oversee
personnel performing data entry, data reconciliation, and data
discrepancy resolution tasks.
* Perform study close out activities working with internal team
and/or CRO per project timeline. Ensure data management
documentation is appropriated filed in the electronic trial master
* Provides database expertise through attendance at meetings and
membership on various committees and teams, as required.
* Participate in the development of SOPs and policies to ensure
that databases are maintained in compliance with regulations.
Minimum Education, Experience and Skills
* Bachelor s degree in statistics, mathematics, computer science,
biology or related scientific field. Master's preferred.
* At least 6 years of relevant data management experience in a
pharmaceutical, biotech, CRO or other clinical research setting.
CCDM certification preferred.
* 2-3 Yrs as study Lead Data Manager
* Experience managing clinical study data using EDC systems;
familiar with multiple phases of clinical development. Prior
database development experience.
* Demonstrated ability in developing study documents, particularly
CRFs, edit check specifications, and DMPs
* Sound background in CDM tasks and documentation in preparation
for study close-out, regulatory submissions, and possible health
* Experience with IXRS, ePRO/eDiary, medical coding, and SAE
* Working knowledge of GCP, ICH, FDA and HIPAA regulations and
* Hands-on experience and in-depth knowledge in CDISC standards,
including CDASH, SDTM controlled terminologies, aCRF, cSDRG, and
* Ability to work independently, self-directed, as well as
collaboratively in a team
* Excellent organizational, written, verbal, and interpersonal
communication skills with great attention to details and ability to
multitask. Demonstrated ability to communicate with non-data
* Ability to work proactively and effectively in a fast paced, high
* Excellent computer skills and proficient in the used of Adobe
Acrobat and Microsoft Office products.
* Experience with CRO and/or vendor management a plus.
* Experience with additional statistical software such as SAS, R
and JMP is a plus.
There are physical/mental demands and work environment
characteristics that must be met by an individual to successfully
perform the essential functions of the job. This information is
available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with
disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action
Employer and values the diversity of our workforce. Emergent does
not discriminate on the basis of race, color, creed, religion, sex
or gender (including pregnancy, childbirth, and related medical
conditions), gender identity or gender expression (including
transgender status), sexual orientation, age, national origin,
ancestry, citizenship status, marital status, physical or mental
disability, military service or veteran status, genetic information
or any other characteristics protected by applicable federal, state
or local law.
Information submitted will be used by Emergent BioSolutions for
activities related to your prospective employment. Emergent
BioSolutions respects your privacy and any use of the information
Emergent BioSolutions does not accept non-solicited resumes or
candidate submittals from search/recruiting agencies not already on
Emergent BioSolutions approved agency list. Unsolicited resumes or
candidate information submitted to Emergent BioSolutions by
search/recruiting agencies not already on Emergent BioSolutions
approved agency list shall become the property of Emergent
BioSolutions and if the candidate is subsequently hired by Emergent
BioSolutions, Emergent BioSolutions shall not owe any fee to the
Keywords: Emergent BioSolutions, Redwood City , Lead Clinical Data Manager, Healthcare , Redwood City, California
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