Januxrx4mo ago

USD 168000–175000/yr

Senior Manager, Clinical Data Management

United States·San DiegoFull-Timesenior

OtherData Management

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To support our growth, Janux Therapeutics is searching for a Senior Manager of Data Management to manage day-to-day operations of data management activities. The Senior Manager will ensure compliance with regulatory requirements and industry standards to improve operational efficiency. They will also manage activities with vendors to support our oncology clinical trials and maintain high quality data management deliverables in a timely manner.

This role needs a proactive, and resourceful professional who has strong experience in hands-on data management activities within oncology indications.

Develop and oversee project level data management strategy.

Oversee CRO data management activities that support clinical trials.

Provide expertise to clinical development functions in data capture, handling, and data management processes.

In-study management for data management activities for Janux clinical studies, including coordinating tasks and deliverables across multiple clinical trials.

Evaluate Electronic Data Capture (EDC) and eSource data capture (ePRO) for implementation.

Contribute toward the drafting and implementation of Data Management Standard Operating Procedures (SOP) in collaboration with cross functional teams per regulatory requirements (ICH/GCP/CFR) and uphold industry standards in vendor outputs (SDTM/CDISC and CDASH).

Act as primary Data Management contact for assigned projects to cross functional teams.

Review clinical documents (eg. Protocols, Case Report Forms, Statistical analysis outputs, and clinical study report).

Review and/or develop all core Data Management Documents, including but not limited to Data Management Plans, eCRF Specifications, Data Validation Specifications, CRF Completion Guidelines, Data Transfer Agreement(s) (DTAs), Data Review Plans, and Data Integration Specifications for clinical studies.

Assist in and/or oversee external data reconciliations (SAE, central labs, etc.).

Oversee and approve the User Acceptance Testing (UAT) of EDC, including relevant documents as needed due to protocol amendments or study needs.

Ensure clinical data within EDC is of high quality for statistical review, interim review, and/or final database lock. Coordinate data reviews between cross functional teams at Janux.

Manage projects assuring timeline and budgetary compliance in data management.

Participates in the preparation and presentation of data, when applicable. Represent Data Management in Sponsor/Regulatory Agency assessments and/or audits.

Up to 20% travel may be required based upon business needs.

Perform other tasks as necessary.

Bachelor’s degree required, advanced degree preferred. A degree in Biomedical or Life Sciences is preferred.

6+ years of Data Management in pharmaceutical, biotech, and/or CRO, including 3 years of Management experience, including vendor oversight.

Advanced knowledge of data management process for clinical trials and the applicable regulations, experience in oncology and early phase studies required.

Ability to coordinate and drive delivery of activities of outside Data Management vendors.

Knowledge of and experience with EDC databases (especially Medidata Rave) integrations between EDC and IRT systems, CDASH/SDTM standards, medical terminology, medical coding dictionaries, data reconciliations, and quality control processes.

Knowledge and understanding of GCP, ICH and FDA requirements as applicable for Clinical Data Management (CDM).

Ability to manage multiple initiatives and shift priorities within a small biotech environment.

Excellent interpersonal skills, strong verbal and written communication skills with the ability to work independently and collaboratively in a dynamic team environment.

Job Type: Full-time

Benefits:

· Annual bonus program

· Incentive stock option plan

· 401k plan with flat non-elective employer contribution

· Comprehensive medical insurance with 90-100% employer-paid premiums

· Dental and vision insurance

· HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity)

· Unlimited PTO

· Generous holiday schedule; includes summer and winter company shutdown

· Relocation assistance

Schedule:

· Monday to Friday

Work authorization:

· United States (Required)

Additional Compensation:

· Annual targeted bonus %

Work Location:

· Hybrid preferred in San Diego office. Remote permitted upon approval, with ability to travel up to 25% for meetings or site visits as required.

EQUAL OPPORTUNITY EMPLOYER:

Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.