Lead Clinical Data Manager
Company: Linical Americas
Location: Stuart
Posted on: February 15, 2021
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Job Description:
Linical is an industry leading, midsized, global contract
research organization (CRO) with a significant footprint across
North America, Europe, and Asia-Pacific. Linical provides the full
spectrum of drug development services from early stage to
large-scale, multinational studies. Our areas of expertise include
Phase I-IV oncology, vaccine, infectious disease, CNS, and general
medicine. Linical is the ideal partner for drug developers looking
to expand their program into new markets, combining strong business
and operational perspective with clinical and medical
expertise.
We have an exciting career opportunity in the position of Clinical
Data Manager/Sr. Clinical Data Manager. This position is a
remote/home based role located anywhere in the USA or Canada.
POSITION DESCRIPTION
The Clinical Data Manager/Senior Clinical Data Manager will lead
and/or perform, with quality, all data management activities for
one or more projects. Senior Clinical Data Managers independently
lead multiple, high volume and extremely complex studies to deliver
accurate, timely, consistent, and quality clinical data. Clinical
Data Managers perform the same study leadership, though the number
of projects and/or complexity may be reduced. The role will mentor
other staff as well as be responsible for customer contact and Data
Management functional, administrative, and financial oversight of
projects assigned.
DUTIES AND RESPONSIBILITIES
Works with project management to define timelines for assigned
studies to ensure critical data management milestones are met
Assists in forecasting data management resourcing for assigned
studies
Performs monthly revenue recognition for data management
activities
Monitors study progress to ensure data management tasks meet study
budget and timelines
Represents data management on study teams and client meetings,
regularly informs project management and client of overall study
status and potential problems
Leads a multi-functional project team of biometrics resources
including database programmers, clinical data coordinators, and SAS
programmers
Identifies and implements solutions for study data management
issues and concerns, including proactive prevention strategies
based on metrics and forecasts
Identifies potential out of scope activities to project and
functional management and assists with the contract modification
process
Performs tasks related to all aspects of the data management
process from study start through database lock for both paper-based
and electronic data capture (EDC) trialsReviews study protocols to
determine data management requirements
Designs Case Report Forms (eCRF/CRF) to efficiently capture all
data required by the protocol
Develops study specific Data Management Plan according to
established procedures
Creates Data Cleaning Plans to ensure the data's integrity and to
identify any outlying values
Assists in building study databases or facilitates EDC vendor
management of database build
Performs User Acceptance Testing of EDC databases and validates
paper CRF databases
Conducts Quality Control review of eCRFs/CRFs, Data Management
Plans, Data Cleaning Plans and databases created by other data
managers
Reviews study database for incomplete data and outstanding data
quality issues
Works with sites and study monitors to follow up on query responses
and errors identified during data cleaning
Manages data provided by third-party vendors (e.g., defines data
handling conventions, edit checks, quality acceptance and auditing
criteria; reconciles external data against the clinical data;
resolves data discrepancies between the external data and the
clinical data)
Performs SAE/ external data reconciliation
Directs database quality control process
Oversees the coding of clinical data (adverse events, concomitant
medications) using standard coding dictionaries
Provides database lock per study timeline
Follows all Standard Operating Procedures (SOPs) and working
practices
Participates in the development and maintenance of SOPs and working
practices related to data management activities
Mentors junior level staff and peers and assigns, reviews and
checks the work of others performing similar duties
Participates in the identification, review, and evaluation of new
data management technologies
Participates in Sponsor Face to Face Meetings (Kick-Off Meetings,
Investigator Meetings, etc.) and business development opportunities
as needed
Other duties as assigned
REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in a life science or industry-related field is
preferred
Excellent working knowledge of ICH, GCP, and FDA guidelines and
regulations
InForm, Medrio, Medidata RAVE, and/or Viedoc database and Microsoft
Project experience preferred
Our employees enjoy a full range of comprehensive benefits to
include but are not limited to medical, dental and vision
insurance, company paid life insurance, paid holidays, PTO, 401K
with employer match, long and short-term disability, and long term
career growth and development opportunities. If you have the
experience required and are looking to join an energetic and
collaborative team, please apply directly to our website at
www.linicalamericas.com.
Linical Americas is an equal opportunity employer. Qualified
candidates will receive consideration for employment without regard
to race, color, religion, sex, sexual orientation, gender identity,
national origin, disability or protected veteran status.
Keywords: Linical Americas, Palm Beach , Lead Clinical Data Manager, Executive , Stuart, Florida
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