Electronic Data Capture (EDC) Build Specialist

Company: Takeda Pharmaceutical
Location: Jersey City
Posted on: May 13, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAs the Electronic Data Capture (EDC) Build Specialist you will oversee delivery of systems and documentation to support of Clinical studies. You will work with Takeda study team to build or oversee implementation of eCase Report Forms (eCRFs) for clinical trials. You will provide consulting services to ensure implementation of technology.You will work with Data Management and standards teams to implement new processes. You will enhance existing processes for efficient and compliant way of Clinical trial build. The EDC Build Specialist maintains and serves as an expert for implementation of EDC best practices.The EDC Build Specialist would be familiar with leading EDC technologies available on the market. You will continue developing new skills associated with EDC technologies.Key Accountabilities

• Partner with appropriate team members to establish technology standards and governance models
• Establish and support business process SOPs.
• Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT, and Quality organizations
• Be a primary change agent to ensure adoption of new capabilities and business process
• Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality.
• Work with leaders to resolve issues affecting the delivery of clinical trials
• Lead technology vendor oversight activities.
• Be a process expert for operational and oversight models.
• Partner with appropriate team members, technology vendors, and CRO partners to avoid and resolve risks.
• Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents
• Participate in preparing function for submission readiness and may represent Clinical Information Operations (CIO) group in a formal inspection or audit.
• Track study deliverables and evaluate study metrics to mitigate risk for major data management deliverables.Education and Experience Requirements:
  • Bachelor's degree or related experience.
  • Knowledge of drug development process.
  • 7+ years experience in Data Management, Programming, Clinical IT, or other Clinical Research related fields.
  • Understanding of industry standard technologies to support Clinical Development needs (e.g. CTMS, SAS, Data Warehouses, Sharepoint)This job posting excludes CO applicants.Location: Cambridge - VirtualBase Salary Range: $120,500-140,000 based on candidate professional experience level. Employee may also be eligible for Short Term and Long Term incentive benefits. Employees are eligible to participate in Medical, Dental. Vision, Life Insurance, 401(k), Charitable Contribution Match, Company Holidays, Personal & Vacation Days, Student Loan Repayment Program and Paid Volunteer Time Off. If candidate is not eligible for any benefits or other comp., those can be excludedThis posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. - 8-5-101 et seqTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Jersey City , Electronic Data Capture (EDC) Build Specialist, Other , Jersey City, New Jersey