New · posted Nov 13
Roche · Pharmaceuticals
Clinical Data Manager I
- Tucson, AZ
- On-site
- Full-time
- Associate & Specialist
The role
As Clinical Data Manager I, you will perform data management activities for both clinical studies and development projects as assigned. You ensure the delivery of complete, accurate data that is ready for analysis and regulatory submission. You support all data-related activities, including data entry, verification, and scribing when needed.
- You are supporting Lead Data Managers in execution of assigned tasks.
- You are assisting and contributing to the compilation of all data management documentation for assigned projects. Review and adhere to the requirements of study-specific DMP. You are participating in study-specific data entry training and serves as backup to data entry staff.
- You are preparing and entering test data for user testing of clinical database and edit checks.
- You are performing basic clinical study data review as required. Identifies incomplete, erroneous, and/or discrepant data.
- You are generating discrepancies and updates clinical database based on queries, data clarification forms, discrepancy management guidelines, and performs other database changes as necessary for a study.
- You are assisting in preparation of relevant subject data files and study documentation for audits and quality control. You are performing other duties as assigned.
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
What you need
- You have a Bachelor's Degree
- Experience required: entry level with great communication skills and the ability to work with relevant computer software, including spreadsheets, word-processing and database packages
Behaviours, competencies and qualities of the ideal applicantnice to have
- Ability to work under time pressure while maintaining high standards of precision and data quality
- Experience with Python scripting, Java and SQL preferred.
Relocation benefits are not offered for this job posting.
The expected salary range for this position, based on the primary location of Tucson, is 55,700 - 87,560 USD Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits
Pay and benefits
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Discretionary annual bonus
Where you'll work
Tucson, AZOn-siteOpen in Maps (opens in a new tab)
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From the posting
About Roche
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Equal opportunity, accessibility and legal noticesRoche's statements, word for word
Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
Job intelligence
The context around this role
Live data · November 13, 2026
Career trajectory
Where this role sits in Clinical Data Management
The general path across 62 open Clinical Data Management roles on Regulatory Jobs, with the titles they carry most. Not Roche's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 14 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs3
- Data and digital systems3
- Collaboration and leadership3
- Clinical trial conduct2
- GMP and compliance1
- Lab testing and methods1
- Regulatory submissions1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Data Management work in pharmaceuticals, each linked to the agency or standards body that publishes it.
- CDISCCDISC standards(official source, opens in a new tab)SDTM, ADaM and CDASH, the clinical data standards FDA and PMDA require
- FDAFDA study data standards(official source, opens in a new tab)Required data standards and technical conformance for clinical study data
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trials
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- ICHMedDRA(official source, opens in a new tab)The ICH medical terminology for coding adverse events and medical history
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- ICHICH E3(official source, opens in a new tab)Structure and content of clinical study reports
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
Company hiring pulse
Roche on Regulatory Jobs
- 8
- Open roles
- 8
- Distinct roles
- 4
- Locations
By discipline
- Regulatory3 38%
- Clinical3 38%
- Quality2 25%
By level
- Senior & Principal3 38%
- VP & Executive2 25%
- Manager2 25%
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Clinical Data Manager I at Roche
Applications close November 18.