Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd., a leading Japanese pharmaceutical company with state of the art research capabilities - that has provided innovative medicines essential to people's health for over 135 years.

In the US, Shionogi Inc. develops and commercializes pharmaceutical products that address unmet medical needs in the areas such as pain and anti-infectives.

The Director, Clinical Data Management provides direction, oversight and coordination of all data management (DM) activities according to quality standards, regulatory requirements, and project budget from study start-up through archival in support of Shionogi development programs.

The Director has strategic responsibility for oversight of Contract Research Organizations (CROs) performing Data Management activities for Shionogi Inc. studies. The Director has strategic responsibility for all staffing and operational aspects of the data management group, and participates in defining a vision for the department which can be integrated into the overall corporate vision. Develops and implements strategies to actualize goals.

RESPONSIBILITIES

• Provides Clinical Data Management (DM) oversight and strategies to colleagues and direct reports to ensure CROs and vendors are performing in compliance.
• Provides Clinical Data Management oversight and strategies for selection of CROs for data management activities
• Reports CRO and vendor compliance to Shionogi expectations, target dates and contract requirements, to Head of Biometrics at both Shionogi Inc. and Shionogi Headquarters.
• Contributes to development of outsourcing strategies and relationships with outsourcing partners with objective of ensuring data quality and efficiencies through data and process standardization.
• Evaluates Data Management partners and provides study teams with recommendations on selecting DM partners starting from RFP through the contract finalization and subsequently through contract modifications (if applicable) to ensure DM tasks performed with acceptable quality, on time and on budget.
• Provides oversight on quality database validation and deployment for all databases for SI sponsored studies, both internal and externally held databases.
• Ensure consistent processes across all studies for multiple projects and across all CROs and vendors.
• Provides coaching, mentoring and performance management for direct and instructs DM managers on coaching, mentoring and performance management.
• Provides coaching and mentoring for Shionogi DM to enable successful oversight of CROs and vendors.
• Establishes goals, expectations and accountabilities for staff, regularly reviewing DM performance with respect to quality and timeliness standards.
• Contributes to the development and delivery of department goals in support of corporate goals.
• Plans, allocates and prioritizes resources.
• Reviews and approves group deliverables.
• Contributes to development of DM budgets.
• Along with VP of Biometrics, has oversight and approval of DM travel
• Directs teams and ensures all databases are developed, validated and ready for transfer and / or analysis according to policies and procedures, SOP's and work instructions (either by Shionogi or CRO) in compliance with applicable regulations.
• Works in collaboration with QA and other functional groups, develops and updates data management standard processes and procedures in accordance with CFR, GCP, ICH Guidelines and GCOMP minimum standards and best practices.
• Provides technical direction to facilitate the adoption and use of technologies for DM and trial management, especially in relation to efficient technologies and processes to work with CROs.
• Will supervise direct reports and contractors.
• Approximate travel - domestic and international including trips to Shionogi Headquarters - 5%.

Requirements

REQUIREMENTS

• Bachelor's Degree in a relatable field; Master's Degree is preferred.
• Minimum of 10 years of experience in Data Management in pharmaceutical R&D required, including oversight of studies supported by CROs, data import, data cleaning, and custom report generation. OR - Minimum of 10 years at a CRO working in data management, supporting industry sponsored trials.
• Knowledge of all applicable regulations including; CPR, GCP, and ICH Guidelines.
• Minimum of five years of supervisory/management experience.
• Ability to work and collaborate in a global DM organization.
• Experience with Regulatory Inspection activities.
• Ability to promote and maintain a positive and professional attitude.
• Ability to motivate and lead a team of varying levels of status & ability.
• Ability to lead global process improvement efforts, including interactions with CROs.
• Attentive to details and able to independently resolve a variety of issues without close supervision.
• Proven Organization & Planning skills.
• IT literate and knowledge of some Database Review and/or Management Systems (e.g., J-Review, RAVE, Medrio, Clinplus, Omnicomm, MERGE, SAS, Oracle, Clintrials, Oracle Clinical, eDM, etc. - knowledge of all is not necessary).
• Proficient with the application of EDC, IVR, ePRO, and other remote data capture systems in the industry.
• Excellent communication skills - verbal, written & interpersonal.
• Working knowledge of medical terminology and experience with clinical research desired.
• Working knowledge of ICH/GCP and of regulatory obligations of the pharmaceutical industry is essential.
• Ability to articulate clearly and conduct verbal presentations with large and small audiences.
• Ability to travel via automobile and/or airplane.
• Ability to sit for extended periods of time - up to four (4) hours at a time.
• Must live a commutable distance from our Corporate Offices in Florham Park, NJ.

To be considered for this position, you must apply online at: https://www.shionogi.com/careers/careers.html -- and meet the requirements of this opportunity.

We look forward to reviewing your resume & qualifications

• Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.
• Please view Equal Employment Opportunity Posters provided by OFCCP

. * The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)