Principal/Lead Data Manager - REMOTE
Company: Precision For Medicine
Location: San Jose
Posted on: June 26, 2022
Job Description:
Why consider joining us? As a member of our thriving team, you
have the opportunity to work alongside clinical research colleagues
who understand the patients' mindset and their disease experiences.
We help translate science into success for trials with a strategic
and targeted, patient-centric approach. We are specialists who find
solutions for novel trial challenges in our detailed approach
throughout every study phase. From the beginning, we have nurtured
an employee-centric company culture that focuses on patients'
needs. Precision's team-focused culture ensures that team members
will thrive and learn. These important key elements result in high
quality work output while still having fun and giving back to the
patient community.We invite you to explore joining our team who are
dedicated to helping our clients, so that ultimately patients can
receive much-needed treatments whether it is oncology, rare disease
or COVID-19.About You
- Want to do a good job, help others and have a passion for
making a difference.
- Care about patients and understand the importance of quality
data leading to successful outcomes.
- Are highly experienced in clinical data management and have
keen attention to detail, clear communication abilities and
organizational skills.
- Foster and value client and internal team collaboration.
- Have a strong belief that all team members are valuable and
appreciated.
- Enjoy working alongside teammates and having project-specific
data management and managerial support.
- Excited about exercising your data management knowledge and
expertise.
- Look forward to opportunities to be involved in innovative data
management technology initiatives and training.A Glimpse Into The
Day To Day
- You will lead all aspects of the clinical trial data management
process from pre-study start up to post database lock for assigned
projects.
- Collaborate with clients and team members to develop Case
Report Forms (CRFs) and methodical data cleaning strategies to
support protocol endpoints.
- Be involved in the Electronic Data Capture (EDC) clinical
database development and user acceptance testing (UAT).
- Actively cleaning data, managing CRF and query trends and data
reporting to ensure a clean database lock ready for analysis.
- Work alongside key functional areas (such as Project
Management, Biostatistics, Medical, Clinical, Safety, Quality
Assurance, etc.).
- Standard Operating Procedures / Work Flow Tools (SOPs/WFTs);
regulatory directives; study specific plans and guidelines will be
followed.QualificationsMinimum Required: Bachelor's degree or in
country local equivalent or equivalent related experienceOther
Required
- Minimum 2 years' experience for CDM I, 5+ years for CDM II, and
8+ years for CDM III (Senior CDM) utilizing various clinical
database management systems
- Broad knowledge of drug, device and/or biologic development and
effective data management practices
- Proficiency in Microsoft Office: Word, Excel, PowerPoint,
Outlook
- Excellent organizational, interpersonal & leadership
skills
- Professional use of the English language; both written and
oral
- Ability to travel (nominal expected)Preferred: Experience in a
clinical, scientific or healthcare discipline. Understanding of
CDISC standards (CDASH, SDTM, etc.). Academic concentration in one
or more of the following, or related discipline; life sciences,
computer science, or engineering. Advanced degree in clinical data
management, health informatics, biometrics or similar.Precision
medicine is revolutionizing the attack on cancer and rare
diseases-and we are passionate about helping you harness its power.
We strike tumors on a molecular level using biomarkers to link
specific mutations to specific treatments. We combine deep science
with deep data from advanced technological platforms, then layer on
specialized expertise in the design and execution of targeted,
adaptive clinical trials. Ultimately, we deliver robust insights
that inform real-time decisions-and optimize the oncology
development pathway.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, LLCIf 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 For Medicine, San Jose , Principal/Lead Data Manager - REMOTE, Executive , San Jose, California
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