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Job Description

R&D

Department

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 Sr. Manager, Clinical Information Operations Lead eCOA will participate in, and provide business leadership for the following activities:

• 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.
• 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.
• 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).
• Day to day administration of systems, working with stakeholders to drive adoption, identify and resolve usability issues.

Responsibilities

 

• Represents CDO as technology SME’s to recognize areas of potential opportunity, mitigate risks and provide solutions to identified problems.
• Leads cross functional groups in identifying business requirements and technology capabilities to support clinical development needs.
• Collaborates with business users and IT to identify and select technology solutions.
• 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 projects.
• 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 trials
• 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 collaborative.
• Coordinate with business functions to deliver technology related activities.
• Communicates clear and specific expectations to assigned staff members, CROs and vendors. Makes sure they are understood.
• Seeks to accomplish critical tasks with measureable results.
• Delegates appropriate tasks to staff members and contractors to maximize effectiveness of the organization. Gives support, direction, and follow-up without undermining delegated authority.
• Uses appropriate methods and interpersonal styles to develop, motivate, and guide team to success.

Education And Experience Requirements

 

• Bachelor’s degree or related experience is required.
• Knowledge of drug development process.
• 8+ 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 people.
• 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.

Location: Cambridge – Virtual

Base Salary Range is $150,000-180,000 based on candidate’s 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 excluded

This posting is made in compliance with Colorado’s Equal Pay for Equal Work Act, C.R.S.

• 8-5-101 et seq

EEO Statement

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.

Locations

New Jersey – Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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