Principal Clinical Data Manager

Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Principal Clinical Data Manager. This position can be located in Spring House, PA; Beerse, Belgium; Leiden, Netherlands; Breda, Netherlands; Mumbai, India; High Wycombe, United Kingdom; or Allschwil (Basel), Switzerland. Remote locations within North America, India and Europe may be considered on a case-by-case basis and if approved by the company.

The Principal Clinical Data Manager (CDM) will be the data management expert within the Oncology Therapeutic Area and will perform scientific complex clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS). This individual will be a key contact between the SRP and SRS and the other data management functions in order to support flawless data management execution. This position will lead others in recognizing opportunities to strengthen the clinical relationship and to further improve the CDM processes.

The Principal CDM will provide support for the SRPs and SRSs of the program you are assigned to. Tapping into technical and clinical expertise, collaborate with the SRP, SRS and the study team members when implementing the data management related activities for protocols, with focus on the more complex indication and therapy related elements of the study. Review all necessary data flows, the Data Management Plans and perform continuous complex data review activities on the studies in your program.

The Principal CDM will work independently and work is reviewed during major deliverables and completed in collaboration with the Data Management Leaders (DML), the DM TA head and the Data Management Operations head, or with Data Management Infrastructure Organization. This person will have no direct reports and will coach CDMs, Senior CDMs and CDM Specialist on compound level responsibilities and may delegate work.

**Qualifications**
- A minimum of a Bachelor’s degree in a Scientific discipline is required. Advanced degree (Master’s, PhD ) in a Scientific discilpine is preferred.
- A minimum of 7 years of experience in data management (specifically in clinical data review), or significant experience with clinical data review is required.
- Strong scientific knowledge (educational/professional) is required.
- A minimum of 5 years experience in the Oncology Therapeutic Area is preferred.
- Experience in clinical drug development within the Pharmaceutical industry, Contract Research Organization or related industry is required.
- Knowledge of medical terminology is required.
- Knowledge of current industry standards (i.e., CDISC, SDTM, CDASH) preferred.
- Team leadership experience is preferred.
- Must have excellent verbal and written communication skills.
- Must have the ability to adapt to a rapidly changing organization and business environment.
- The ability to collaborate with clinical teams and all levels of management across a matrix environment is required.
- This position will require up to 10% travel.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

GIFTS

**Primary Location**
United States-Pennsylvania-Spring House-Welsh & McKean Roads
**Other Locations**
Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America, Europe/Middle East/Africa, Europe/Middle East/Africa-Netherlands-North Brabant-Breda, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Switzerland-Basel-City-Basel, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Asia Pacific-India-Maharashtra-Greater Mumbai
**Organization**
Janssen Research & Development, LLC (6084)
**Job Function**
R&D
**Requisition ID**
2206015748W