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Associate Director, Data Management

Company

Otsuka

Address , Remote
Employment type FULL_TIME
Salary
Expires 2023-06-26
Posted at 1 year ago
Job Description
Job Summary
Otsuka is a healthcare company driven by our purpose and defined by our beliefs. Otsuka DM is part of the Clinical Analytics department and supports the efficient and effective development and delivery of the clinical pipeline. The Associate Director of Data Management supports the Director in providing leadership, direction, and operational management for the data management team. This is a leadership position responsible for line managing, developing and accountability for the Protocol Data Managers in their assigned program; and for meeting assigned operational targets including but not limited to quality, performance, utilization, retention and training.
  • Participate in the development and maintenance of standard eCRFs and associated edit specifications.
  • Provide consultation, leadership, and expertise to clinical development functions in the areas of data handling and data management processes.
  • Identify and implement methodologies and technologies to best support projects.
  • Establish and manage data capture, management, and review standards to ensure the quality and integrity of clinical research data in compliance with global regulatory requirements.
  • Participate in new hire process, onboarding activities, mentoring and training of DM staff.
  • Drive continual improvement across a program and effectively share lessons learned and best practices across projects/programs.
  • Develop and maintain SOPs and working practice documents for data management tasks in collaboration with representatives from other functions and therapeutic areas.
  • Represent data management on key company initiatives.
  • Proactively identify risks and executes risk mitigation strategies.
  • Maintains timely communication with management and cross-functional teams.
  • Represent Clinical Data Management on the program governance teams / joint operations committees
  • Manage the scope, budget, and resources for assigned projects/programs.
  • Evaluate Electronic Data Capture (EDC) and other data collection technologies for implementation.
  • At a program level, act as Data Management expert to develop data management strategies,
  • Line management and setting performance expectations for assigned direct reports.
Qualifications/ Required Knowledge/ Experience and Skills:
  • Demonstrated project management experience with ability to perform under tight timelines while balancing conflicting priorities.
  • Excellent communication, interpersonal, and presentation skills.
  • Working knowledge of data management process for clinical trials and current regulations.
  • Strong organizational, time management, and resource-allocation skills with the ability to perform and prioritize multiple tasks and programs with excellent attention to detail.
  • Management skills to accomplish work through others and maintain appropriate relationships
  • Experience with regulatory audits and inspections.
  • Deep understanding of ICH GCP guidelines, CDASH standards, and other applicable regulatory rules and guidelines.
  • Travel (approximately 30%).
  • Experience working with and managing external service providers/vendors.
Educational Qualifications:
  • Bachelor's or Master's degree (preferred) with a minimum of 10 years of experience in pharmaceutical industry
#MS1
Come discover more about Otsuka and our benefit offerings;
https://www.otsuka-us.com/careers-join-otsuka
.
Disclaimer:
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
Valid Proof of COVID-19 Vaccination or Accommodation
The COVID-19 Vaccination is mandatory for incoming new hires and employees. Uploading documentation with proof of full vaccination record or an Otsuka approved accommodation will be required during the pre-employment process as permitted by law. New hires must be fully vaccinated unless there is an approved accommodation prior to start date.
Statement Regarding Job Recruiting Fraud Scams
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website
https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External
.
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at:
https://www.ic3.gov
, or your local authorities.