Clinical Information Operations eCOA Data Manager Lead
Company: Takeda Pharmaceutical
Location: River Edge
Posted on: May 11, 2022
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in my employment application is true to the best of my
knowledge.Job DescriptionPosition Title:Clinical Information
Operations LeadR&DDepartment:Reports into Clinical Information
Operations Team Lead. - -Provides leadership and expertise for CDO
technology strategy and initiatives to address CDO business
objectives. Responsible for defining and ensuring support is
provided for Clinical Development Operations (CDO) systems. Ensures
support for CDO sub functions as assigned (e.g. Biostatistics &
Programming, Clinical Programs, Study teams, Document Management,
Clinical Trial Transparency). Partners with key business users and
IT to provide support for intended use of systems. Supports
definition and implementation of business processes.The Clinical
Information Operations Lead will participate in, and provide
business leadership for the following activities:1. Implementation
of new CDO systems or upgrades to existing systems. This person
will ensure new, upgraded, or current CDO systems are supported and
maintained, delivers intended functionality, appropriate business
processes are developed, and that users are optimally trained.2.
Identification of new cost effective solutions to support the
optimal delivery of clinical programs. Will work with business
representatives, CROs, vendors and IT to ensure successful delivery
of solutions. -3. Coordination and participation with external
parties (Vendors and CROs) to ensure proper functioning and
business support of identified CDO capabilities (e.g. data
exchange, SAS, data warehouse, document exchange). -4. Day to day
administration of systems, working with stakeholders to drive
adoption, identify and resolve usability
- Represents CDO as technology SME's to recognize areas of
potential opportunity, mitigate risks and provide solutions to
- Leads cross functional groups in identifying business
requirements and technology capabilities to support clinical
- Collaborates with business users and IT to identify and select
- Ensures business user acceptance testing is conducted
- Ensures training of staff to optimally use technologies.
- Leads business resources to develop and deploy appropriate
business processes to support technology solutions.
- Acts as primary business project manager for technology
- Leads in the deployment of technologies and business process
across the CDO organization.
- Acts as primary business change agent to ensure adoption of new
capabilities and business process
- Collaborates with leaders of supported business functions to
identify and resolve issues impacting delivery of clinical
- Leads collaboration with CROs and vendors to ensure services
and business tasks are executed as per contract and SLAs
- Assesses technology planning for proposed changes, contingency
plans and integration work streams.
- Evaluates new technology deployment strategies and activities
to ensure optimal benefit for CDO and Shire.
- Keeps current with industry developments and strategies related
to clinical technologies.
- Consults with supported business functions to identify gaps,
risks, and inefficiencies.
- Acts as expert resource (SME, PM) to ensure acquisition,
deployment and operation of clinical technologies.
- Leads in developing trust through transparency in communication
and individual actions. Ensure outcomes are team driven and
- Coordinate with business functions to deliver technology
- Communicates clear and specific expectations to assigned staff
members, CROs and vendors. Makes sure they are understood.
- Seeks to accomplish critical tasks with measureable
- Delegates appropriate tasks to staff members and contractors to
maximize effectiveness of the organization. Gives support,
direction, and follow-up without undermining delegated
- Uses appropriate methods and interpersonal styles to develop,
motivate, and guide team to success.Education and Experience
- Bachelor's degree or related experience is required.
- 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, etc.)Key Skills, Abilities, and Competencies
- Demonstrated knowledge of drug development process.
- Demonstrated knowledge of clinical technologies.
- Strong attention to detail.
- Ability to present complex technical issues to non-technical
- Proven ability to manage staff and communicate effectively with
internal and external personnel.
- Demonstrated ability to lead teams and work groups.
- Ability to work independently, takes initiative, and complete
tasks and make deadlines.
- Excellent verbal and written communication skills, ability to
communicate effectively to multiple levels of the organization with
strong negotiation skills.Base Salary Range: $120,000-140,000 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.Effective November 1, 2021, 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. As of the same date, absent an approved religious or
medical reason, US field-based employees, employees must be fully
vaccinated in order to continue in their current roles. 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. Candidates are encouraged to speak with their
recruiter to seek further information on the applicable guidelines
for the Business Unit/Function for which they have applied.Takeda
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.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, Clifton , Clinical Information Operations eCOA Data Manager Lead, Executive , River Edge, New Jersey
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