Clinical Data Manager

Tampa, FL - USA

Monthly Salary: Not Disclosed

Posted on: 8 hours ago

Vacancies: 1 Vacancy

Job Summary

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!

Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race color creed religion ancestry age sex marital status national origin disability or veteran status.

Why youll love working atAxogen:

Friendly openandfunteam culturethat values uniqueperspectives
Company-wide dedicationto profoundly impacting patients lives
Comprehensive high-quality benefitspackage effective on date of hire
Educationalassistanceavailable for all employees
Matching 401(k)retirementplan
Paid holidaysincluding floating holidaysto be used at your discretion
Employee Stock Purchase Plan
Referral incentive program

Axogen Mission and Business Purpose

Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions we will guide and expect the market and design requirement specifications underlying our engineering business development and clinical research activities objectively target advancements in standards of care.

Job Summary of the Clinical Data Manager

The Clinical Data Manager performs hands-on clinical data management activities across Axogens clinical studies with primary responsibility for supporting study start-up activities overseeing data collection performing data cleaning and conducting ongoing data review to ensure adherence to study protocols. This role is accountable for maintaining accurate complete and inspection-ready clinical data from study start-up through database lock.

The Clinical Data Manager works closely within the core Data Management team and partners with Clinical Operations Biostatistics Medical Clinical Systems Quality and external vendors to support eCRF design edit check development data review reconciliation and regulatory readiness. This is an individual contributor role reporting to the Director Clinical Data Management & Systems.

Requirements of the Clinical Data Manager

Bachelors degree in a health science life science mathematics or related field required; masters degree preferred
36 years of hands-on clinical data management experience in a medical device biotech or pharmaceutical environment
Experience performing data cleaning query management ongoing data review and reconciliation activities
Experience working in an Electronic Data Capture (EDC) system required; experience with Veeva EDC preferred
Working knowledge of GCP ICH guidelines and 21 CFR Part 11 requirements
Strong analytical and problem-solving skills with the ability to identify trends and resolve data quality issues
Ability to manage multiple priorities across studies with consistent follow-through
Demonstrated ability to work independently while collaborating with Clinical Data Management leadership and cross-functional partners to evaluate issues and align on data management decisions
Familiarity with CDISC standards and industry best practices preferred
Certified Clinical Data Manager (CCDM) certification or professional involvement with the Society for Clinical Data Management (SCDM) a plus
Sponsor-side clinical data management experience preferred
Experience supporting database lock and regulatory inspections preferred

Responsibilities of the Clinical Data Manager

The specific duties of the Clinical Data Manager include but are not limited to:

Study Start-Up and Systems Interaction
- Interpret study protocols to support eCRF design and development
- Create and review edit checks to ensure data capture and validation align with protocol requirements
- Review EDC builds and participate in UAT to confirm eCRFs and edit checks function as intended
- Support production release readiness and assess the impact of study changes on data quality and review workflows
- Assess protocol amendments to determine data eCRF and edit check impacts and support required database updates
- Partner with Clinical Systems and vendors to review test and validate database changes resulting from protocol amendments or system releases

Data Collection Cleaning and Review
- Perform hands-on oversight of clinical data collection activities to ensure alignment with study protocol requirements
- Perform data cleaning and ongoing data review from study start-up through database lock
- Evaluate edit check performance during study conduct and support updates as needed
- Generate review prioritize and resolve queries in collaboration with investigative sites and vendors
- Review data listings and other review outputs to identify discrepancies trends and data quality risks
- Track data issues through resolution to support study timelines and database lock readiness
- Perform and support reconciliation of clinical data with external data sources as applicable
- Support post-implementation review of database changes to ensure data integrity and continued protocol adherence

Collaboration and Execution Support
- Work closely within the core Data Management team as well as Clinical Operations Clinical Systems Biostatistics Medical Monitoring Quality and external vendors to ensure accurate complete and inspection-ready clinical data throughout the study lifecycle
- Support interim data reviews data cuts and database lock activities
- Communicate data issues clearly and proactively to appropriate stakeholders

Quality and Compliance
- Perform data management activities in accordance with SOPs GCP ICH guidelines and 21 CFR Part 11 requirements
- Maintain inspection-ready documentation supporting data review reconciliation and data quality decisions
- Support audits and inspections by clearly explaining data review activities decisions and outcomes

Location

111 West Oak Ave. Tampa FL 33602

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Benefits/Compensation

This position is eligible for an annual bonus.

Benefits offered for this position include Health Dental Vision Matching 401K Paid Time Off 9 Paid Holidays 3 Floating Holidays Dependent Care Flexible Spending Accounts Medical Flexible Spending Accounts Tuition Reimbursement Paid Parental Leave Paid Caregiver Leave Basic Life Insurance Supplemental Life Insurance Employee Stock Purchase Plan and Disability Insurance as described in more detail in summary plan descriptions.

Salary Range

$92293$115367 USD

Axogen follows healthcare system guidelines with respect to credentialing vaccinations and other employment/compliance related requirements as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.

Required Experience:

Manager