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Manager Clinical Data Management
Company: Otsuka Pharmaceuticals
Location: Princeton, NJ
Employment Type: Full Time
Date Posted: 12/04/2022
Expire Date: 02/04/2023
Job Categories: Biotechnology and Pharmaceutical
Job Description
Manager Clinical Data Management
Job Summary
Otsuka DM is part of the Clinical Analytics department and supports the efficient and effective development and delivery of the clinical pipeline. The Project Data Manager (PDM) coordinates assigned clincial data management activities for clinical studies and represents Data Management as the primary point of contact with clients and internal members of the study team.

Job Description
Serve as Clinical Data Management Lead on all assigned projects and activities.
Develop study specific eSource or electronic Case Report Forms (eCRF), ensuring consistency with study protocol, clinical requirements, and accurate and efficient data collection.
Responsible for clinical database management, data verification, data cleaning, and quality assurance of multiple projects.
Provide strategic input into protocol design and ensure protocol can be operationalized from a data management perspective.
Represent Data Management on project teams as needed.
Ensure timely completeness and accuracy of databases.
Attend/conduct meetings, teleconferences and webinars relevant to current or upcoming projects.
Provide status reports on the progress of projects to study team.
Create and maintain data management documents per SOP (e.g. Data Management Plan, User Acceptance Testing Plan, Edit specifications, CRF Completion Guidelines, etc.).
Ensure data management related presentations for Investigator's meetings adhere to Otsuka requirements.
Oversee the Contract Research Organization (CRO) and third-party vendor processes involved in developing data collection systems, data cleaning and providing data deliverables conforming to global Otsuka standards.
Work collaboratively with CROs and third-party vendors to design database, define quality specs, and resolve data management-related issues for outsourced studies.
Adhere to DM standards and processes for both in-house and CRO studies in accordance with Good Clinical Practices (GCP).
Ensure standard processes are followed by all CROs for data management activities. Train CRO personnel on current processes and ensure compliance.
Manage third party vendors (e.g., CROs) processes, and local/central laboratories on defined data standards, content specifications, and timelines for deliverables.
Maintain a thorough understanding of regulatory requirements for clinical trials.
Proactively identify and implement opportunities for process improvements.
Other tasks/deliverables as assigned.

Qualifications/ Required Knowledge/ Experience and Skills:
Strong understanding of clinical medical concepts and terminology.
Knowledge of Guidelines for GCP, 21 CFR Part 11 regulations, and Regulatory requirements for clinical trials.
Strong working knowledge of data management processes and applicable global regulatory requirements.
Demonstrated ability to prioritize multiple projects and deliverables.
High attention to detail, ability to multi-task and be collaborative.
Strong computer skills with demonstrated experience in Microsoft Office Software.
Oral and written communication/presentation skills.

Educational Qualifications
Bachelor's degree with a minimum of 4 years of experience in pharmaceutical industry.
Basic understanding of clinical development and data management processes; or equivalent combination of education and experience.


Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.


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.
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