Manager Data management - REMOTE
Company: Precision Medicine Group
Location: San Jose
Posted on: May 16, 2022
Job Description:
Position Summary
The Manager, Data Management manages the day-to-day activities of
the Data Management function in accordance with Standard Operating
Procedures (SOPs), regulatory directives; and study specific plans
with an emphasis on effective resourcing and development of
personnel. Provides oversight and leading activities for data
management projects; coordinates inter-departmental and client
communication and helps resolve administrative, personnel, and site
issues. In addition, manages all aspects of the clinical trial data
management process from study start up to post database lock for
Electronic Data Capture (EDC) and paper CRF trials. This position
will also oversee and/or perform database development and
testing.
Essential functions of the job include but are not limited
to:
- DM Oversight of sponsor programs. May be the primary DM contact
(Lead DM role) for assigned clinical project(s) / program(s),
ensuring that there is back-up, continuity, responsiveness, and
that tasks are performed in a timely manner for all studies for
these clients. May include DM oversight of sponsor programs.
- Oversee project data entry process including development of
data entry guidelines, training, data entry quality and
resourcing
- Provide input, assesses and manage timelines. Ensure that
clinical data management deadlines are met with quality. Assess
resource needs for assigned projects, as needed.
- May develop CRF specifications from the clinical study protocol
and coordinate the review/feedback from all stakeholders
- May assist in building clinical databases
- May conduct database build UAT and maintain quality controlled
database build documentation. Oversee overall quality of the
clinical database.
- May specify requirements for all edit check types e.g.
electronic, manual data review, edit checks, etc. Oversee
development of the edit check specifications and manual data review
specifications
- Responsible for creating, revising, appropriate versioning and
maintaining data management documentation. Oversee completeness of
data management documentation for the Trial Master File.
- Train clinical research personnel on the study specific CRF,
EDC, and other project related items as needed.
- May review and query clinical trial data according to the Data
Management Plan
- May perform line listing data review based on the guidance
provided by the sponsor and/or Lead DM
- May run patient and study level status and metric reporting.
Oversee the development requirements and frequency of report
delivery.
- May perform medical coding of medical terms relative to each
other in order to ensure medical logic and consistency
- May coordinate SAE/AE reconciliation
- Liaises with third-party vendors such as external data and EDC
vendors in a project-manager capacity in support of timelines and
data-related deliverables
- May assist with SAS programming and quality control of SAS
programs used in the Data Management department
- Identify and troubleshoot operational problems, issues,
obstacles, and barriers for studies based on metrics data, audit
reports, and input from project team members and other
stakeholders
- May assist in reviewing and providing feedback on protocols,
Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs),
if required by the project
- Participate in the development and maintenance of Standard
Operating Procedures (SOPs) and corresponding process documentation
related to data management, database management, applications
development and SAS programming activities
- Provide technical and operational guidance and direction,
checking output of project work, ensuring deliverables are met and
performance and professional behavior management
- Attend strategy meetings, bid defense prep meetings, bid
defenses, capability presentations, potential client engagement
meetings
- Reviews Request for Proposals (RFP), proposals, provide project
estimates
- Provide leadership for cross-functional and organization-wide
initiatives, where applicable
- Ensures that all data management project team members have been
sufficiently trained
- Communicate with study sponsors, vendors and project teams as
needed regarding data, database or other relevant project
issues
- Present software demonstrations/trainings, department/company
training sessions, present at project meetings
- Requires some travel
- May perform other duties as assigned
Qualifications
Minimum Required:
- 5+ years' experience
- Bachelors and/or a combination of related experience
Other Required
- Proficiency in Microsoft Office: Word, Excel, PowerPoint,
Outlook.
- Able to handle a variety of clinical research tasks.
- Excellent organizational and communication skills
- Professional use of the English language; both written and
oral.
- Experience in utilizing various clinical database management
systems
- Broad knowledge of drug, device and/or biologic development and
effective data management practices
- Strong leadership and interpersonal skills
- 1+ years of leadership experience
Preferred
- Experience in a clinical, scientific or healthcare
discipline.
- Dictionary medical coding (MedDRA and WHODrug)
- Understanding of CDISC standards (CDASH, SDTM, ADaM,
etc.---)
- Oncology and/or Orphan Drug therapeutic experience
Any data provided as a part of this application will be stored in
accordance with our Privacy Policy .
Precision Medicine Group is an Equal Opportunity Employer.
Employment decisions are made without regard to race, color, age,
religion, sex, sexual orientation, gender identity, national
origin, disability, veteran status or other characteristics
protected by law. - 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable
accommodation to complete any part of the application process, or
are limited in the ability or unable to access or use this online
application process and need an alternative method for applying,
you may contact Precision Medicine Group at
QuestionForHR@precisionmedicinegrp.com .
Keywords: Precision Medicine Group, San Jose , Manager Data management - REMOTE, Executive , San Jose, California
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