Principal Clinical Data Acquisition Expert

Job description

Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting for a Lead Associate, Submission Management with Clinical Trial Application management experience to be part of the Oncology therapeutic area team within Regulatory Submissions Management and Operations.
We discover and develop innovative medical solutions to address meaningful unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.

ROLE PURPOSE
To lead technical clinical data management activities, including the CRF technical development, data model specifications and mapping, data stream integrations, programs, reports and visualizations for data review, eCRF submission packages, You will use novel technologies and systems in the data management space.

You will partner with Global Data Managers and Standards authorities to evaluate and propose optimal technical solutions to meet protocol requirements and determine implementation plans. You will also provide hands-on programming as appropriate in support of a trial. You will take a lead role to ensure consistency and quality within and across trials.

Acting as a deployment authority in the technical aspects of data management ensuring current standards are being utilized, current technologies are deployed and system integrations are optimized. At the trial level, you will drive standards for CRF builds and ensure standard methodologies are used for edit checks, reports, and integrations. Additionally, you will review data models for compliance with standards and will assist with the generation of new CRF, edit check, mapping and submission standards if needed.

There is accountability for the delivery of technical data management components of the trials – data collection with integrations, reports and data are checked for quality review, appropriately formatted datasets (SDTM or other) including the full e-submission ready data package. Working together with the Global Data Manager to ensure the solutions are optimal to deliver the trial data content.

PRINCIPLE RESPONSIBILITIES
- Ensure eCRF is built according to the latest standards and standard methodologies, including edit checks and applicable integrations (IWRS, CTMS, etc); translate protocol requirements into optimal data capture approaches; lead eCRF build and updates by CRO or vendor to confirm quality.
- Provide specifications for data models areused for quality review and for final data model (SDTM or other); design mapping algorithms for non-standard conversions.
- Ensure quality review of datasets (e.g., Pinnacle 21 compliance checking); ensure datasets are available for partner use (medical review, central monitoring, adaptive design, etc) and compliant for Database lock.
- Program, or oversee programming of, quality review checks and reports for use by Global Data Managers and other team members.
- Ensure non-eCRF technologies for data capture (e.g., ePRO, safety reporting, coding, IWRS) are used as required, including integrations with other systems, platforms or reporting environments with timelines for consumable data outlined.
- Oversee development of data transfer agreements with ancillary data vendors ensuring use of standards, fit-for-purpose data models and transfer intervals.
- Maintain working knowledge and expertise in programming languages utilized in data management (SAS, SQL, etc) and apply continuous learning as data management platforms evolve.
- Responsible for creation of submission-ready SDTM packages for FDA/PMDA or other regulatory authority submissions and keeping abreast in changing regulatory requirements

Desired profile

Qualifications :

EDUCATION AND EXPERIENCE REQUIREMENTS

Does this sound like an opportunity of interest? Do you have the following skills and experience?:

- Team leadership experience
- Experienced in and knowledgeable of protocol and current clinical drug development processes
- Knowledge of international guidelines regarding clinical trials end to end
- Experience of eDC systems, e.g. Medidata platform of tools, Clinbase eCOS, etc.
- SAS programming / other analytical programming language skills
- In-depth knowledge of reporting tools, e.g. Spotfire
- Experience in SDTM including Define.xml, CDASH, metadata
- ability to work with multi-functional team interpreting data requirements.
- validated knowledge of good data management practices
- Project management skills and knowledge of team management principles.

We are passionate about our work, and play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. We share a kind of DNA where we're each

- Committed to caring
- Responsible to our communities
- Ready to apply our knowledge and know-how
- Unique in our background and experiences
- The drivers of our own success
- Passionate about doing what's right

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.