The Senior Clinical Data Manager works closely with the Biostatistics, Programming, Clinical and Medical Research groups in all aspects of overseeing the CRO DM OR performing all in-house data management including setting up, managing and completing trials within timelines with the primary goal of ensuring data integrity.

This position entails partnering with cross functional groups and decision making responsibilities regarding trial designs and timelines.

RESPONSIBILITIES

• Support or Manage multiple studies in-house and provide CRO oversight (May operate as the Trial Data Lead (TDL) depending on study needs)
• Coordinate Database build, Design CRF, author Data Management Plan, Data Validation Plan, Edit check specifications and CRF Completion Guidelines for an inhouse study.
• Review and provide guidance/inputs to CRO for all outsourced Data Management activities including but not limited to CRF design, Data Management Plan, Data Validation Plan, Edit check specifications and CRF Completion Guidelines.
• Participate in User Acceptance Testing activities as needed.
• Liaise with Safety team and perform/oversee SAE reconciliation.
• Conduct review of clinical trial data; write/resolve queries and track the status of data cleanliness and perform all tasks required for database lock.
• Respond and provide trial related support to cross functional groups such as Biostatistics, Clinical Research, etc.
• Assist in developing SOP and Working Practices
• Attend meetings and report on study status, metrics, timelines, etc
• Other data management department and trial related activities as delegated
• Entails decision making responsibilities regarding trial database and CRF designs, timelines, vendor selection, and CRO oversight

SUPERVISORY | DECISION MAKING AUTHORITY

• N/A

MINIMUM JOB REQUIREMENTS

• BA/BS in science related field
• 3-4 years’ experience in clinical data management
• Clinical data management background with EDC systems
• Strong project management skills
• Excellent, verbal, written and interpersonal communication skills
• Must live a commutable distance to our corporate offices in Florham Park, NJ

PREFERRED SKILS & EXPERIENCE

• Prior experience of working with studies across all phases or Clinical Development (Phase I – III). Specialized experience with Phase I studies or Post Marketing Surveillance studies or experience of working with Real World Data is a plus.
• Familiarity with tools such as J review, SAS and Excel and proficiency with Electronic Data Capture systems preferably with Medidata Rave. Knowledge of e-source/ePRO/eCOA data is a plus.
• Familiarity with CDASH, SDTM and medical terminology principles in relation to study design
• Experience in RBM, or Centralized Monitoring is preferred.
• Good working knowledge of GCP.

To be considered for this position, you must apply and meet the requirements of this opportunity.

We look forward to reviewing your resume & qualifications.

“Please be aware that Shionogi Inc. mandates COVID-19 vaccination of all employees and contractors regardless of work location. Accommodations may be made in accordance with applicable law.”

DISCLAIMER

The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.

EEO

Shionogi Inc. is an equal opportunity/affirmative action employer.

All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.

It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.