Data Scientist analyzing claims data, optimizing processes and collaborating across departments at Allianz Spain. Utilizing statistical techniques and developing predictive models for operational efficiency.
About the role
- Analyst II Data Manager responsible for overseeing data management activities for clinical trials. Collaborating with partners to ensure data integrity and compliance in healthcare innovation.
Responsibilities
- Take a leadership role with external suppliers, trial customers and other internal/external partners to establish, align and confirm data management and/or clinical data management expectations to the business for assigned trial(s).
- Gather and/or review content and integration requirements for eCRF and other data collection tools.
- Establish conventions and quality expectations for clinical data.
- Establish expectations for dataset content and structure.
- Set timelines and follow-up regularly to monitor delivery of all data management milestones.
- Review clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.
- Ensure compliance with regulatory guidelines and the documentation matrix.
- Ensure real-time inspection readiness of all DM deliverables for the trial and participate in regulatory agency and J&J internal audits as necessary.
- Plan and track content, format, quality, and timing of applicable data management deliverables.
- Ensure deliverables are on time.
- Take a leadership role with the assigned clinical working group(s) to ensure that DM and TA trial needs and deliverables are achieved.
- Create key functional plans (e.g. study Integrated Review Plan) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.
- Identify and communicate lessons learned, best practices, and frequently asked questions at the trial level.
- Identify and participate in process, system, and tool improvement initiatives.
- Perform trial level oversight controls and/or execute data management activities per applicable procedures, with DML direction.
Requirements
- Minimum of Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Clinical Data Management, Health, or Computer Sciences is required.
- Minimum of 2 years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry.
- Experience in clinical drug development within the pharmaceutical industry or related industry.
- Experience working with cross functional stakeholders and teams.
- Strong written and verbal communications skills (in English).
Benefits
- medical
- dental
- vision
- life insurance
- short and long-term disability
- business accident insurance
- group legal insurance
- consolidated retirement plan (pension)
- savings plan (401(k))
- annual performance bonus
- vacation – 120 hours per calendar year
- sick time - 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
- holiday pay, including Floating Holidays – 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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