Clinical Trial Management System Business Administrator

Location
Basking Ridge, New Jersey
Posted
Jul 23, 2021
Ref
10846BR
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Job Summary:

Executes the global Clinical Trial Management System (CTMS) strategy with minimum oversight. Utilizes CTMS tools and technology to accomplish tasks. Proficient in CTMS and clinical operations management. Develop consistent setup and maintenance of CTMS study requirements, processes, and program. Manages and resolves business support questions utilizing service management system within appropriate timeframes. Participate in policy/procedure development and drafting. Serve as CTMS clinical SME to study teams and functions. Provides training and deep dives on CTMS system and business process; Assists with development of business requirements and participates in policy/procedure development and User Acceptance Testing (UAT) of the system. Ensures that the documentation is consistent with the Good Documentation Practices, applicable SOPs, ICH/GCP guidelines as appropriate.

Responsibilities:

Executes multiple, highly complex CTMS related applications simultaneously in a matrix environment.

Train others on the CTMS system and business process.

Identifies, executes, and assists in the development of business process improvement opportunities.

Establishes and maintains effective and timely communication across the global operations group. Works with and represents the Clinical Systems group and business needs as appropriate.

Communicates and actively collaborates with managers and leaders concerning the CTMS business process and helping to achieve organizational goals and objectives.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

Bachelor’s degree in relevant discipline (or equivalent years' experience)

4+ years of experience in the pharmaceutical industry.
Clinical Operations experience, either supporting or managing a study preferred.
Experience in CTMS technology is a plus

Ability to execute and follow-through to completion and documentation.

Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.

Independently motivated, detail oriented and good problem-solving ability.

Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.

Excellent communication skills and ability to influence across multiple functions.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.