Database (Programming) Analyst (Associate), Clinical Data Management

2+ years

Not Disclosed

Remote, USA

10 Nov. 13, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Why Patients Need You

As part of the Clinical Data Science (CDS) group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, Database Analysts play a key role in programming high-quality clinical databases. Their responsibilities include designing, developing, and maintaining clinical databases, ensuring the integrity of clinical data, and applying standards that support consistency in asset/submission data.

What You Will Achieve

You will help strengthen the oversight of clinical data by ensuring stronger ownership, control, and visibility. You’ll be responsible for processing, reviewing, and managing clinical data and records from therapeutic groups and internal/external investigators. Ensuring timely, accurate, and consistent data delivery to clinical teams is key. You’ll also assist in data management plans, data preparation, and validation activities.

As an associate, your focus will help you contribute to the successful completion of project tasks and goals. Your domain knowledge and teamwork will create a collaborative environment that supports your colleagues.

Your commitment and hard work will make Pfizer ready to achieve new milestones and improve the lives of patients globally.

How You Will Achieve It

Contribute to project milestones and meet deadlines by organizing your own work.
Participate in Data Monitoring and Management (DMM) activities, including data review and query management.
Ensure quality database design, including documentation, testing, validation, and implementation of clinical data collection tools and systems.
Ensure all work complies with applicable Standard Operating Procedures (SOPs).
Investigate logic check flags using system information and study documentation.
Liaise with the Study Team Point of Contact, Document Owners, Trial Master File (TMF) Study Owners, and other users to resolve document-related discrepancies.
Identify and investigate potential discrepancies, reviewing findings with the study team.
Contribute to process improvement and manage any additional projects that arise.
Collaborate with department roles and cross-functional study team members to create data capture solutions that ensure the timely delivery of high-quality data.
Learn Pfizer’s database technologies and develop a solid understanding of data capture tools to ensure the accuracy and integrity of study data.

Qualifications

Must-Have

Bachelor’s degree with 1-2 years of experience.
Knowledge of ICH/GCP (International Council for Harmonization/Good Clinical Practice) documentation requirements.
Hands-on experience with electronic documentation management and/or web-based data management systems.
Awareness of the clinical development process, including Good Clinical Practice principles.
Understanding of regulatory requirements and relevant data standards.
Detail-oriented, consistent, and dedicated to excellence.
Strong oral and written communication skills in English.
Proficiency in Microsoft Office tools.

Nice-to-Have

Experience in managing medical and clinical study records and documentation.

Other Job Details

Last day to apply: November 18th, 2024
Work Location: Flexible (approximately 2 to 3 days a week in the office)
Eligible for Relocation Package: NO

Compensation & Benefits

The annual base salary for this position ranges from $64,600.00 to $107,600.00. In addition, the role is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary. Pfizer offers a comprehensive benefits package that includes a 401(k) plan with matching contributions, paid vacation, holidays, personal days, paid caregiver/parental leave, and medical, prescription drug, dental, and vision coverage.

Sunshine Act

Pfizer complies with transparency laws and reports payments and transfers of value to healthcare providers. If you are a licensed physician, reimbursement of recruiting expenses incurred as a result of interviewing with Pfizer may be subject to reporting.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in employment. The position requires permanent work authorization in the United States.

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Database (Programming) Analyst (Associate), Clinical Data Management

Job Description

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