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Manager/Sr. Manager IT R&D
at Radius Health
Waltham, MA

Manager/Sr. Manager IT R&D
at Radius Health
Waltham, MA

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Description

Radius Health

Radius Health is an equal opportunity employer. EEO/Disabled Individuals/Veterans. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HRconnect@radiuspharm.com. Click here to navigate to the EEO is the Law poster. Click here to navigate Radius Healths Pay Transparency Policy.


Manager/Sr. Manager IT R&D

US-MA-Waltham

Job ID: 2020-2048
Type: Regular Full-Time
# of Openings: 1
Category: IT - Dept

Overview

The Manager/Senior Manager for IT R&D controls a portfolio of applications in support of the R&D and Quality business teams. Veeva Vault is a major platform for this portfolio and utilized for QMS, RIM, eTMF and PromoMats, deep experience in at least one of the Vaults is required. Incumbent is responsible for active dialogue on enhancement to the application portfolio and will work closely with application vendors and managed service providers. Larger projects will follow the Radius PMO lifecycle and includes management of outside vendors and staff from other departments to deliver project milestones. Smaller, tactical projects will require hands-on application and project management. Role will also provide supporting services for additional 10+ R&D applications as needed and will ensure all validation compliance is maintained.



Responsibilities

  • Interact directly with Research, Clinical Quality, Regulatory and Pharmacovigilance business partners to build relationships and manage application projects & support. Manage communication with all stakeholders (business partners, IT team, service providers) to ensure they are aware of the status of all work.
  • Understand business initiatives in order to facilitate the definition of project scope, goals, resources and Critically evaluate and manage enhancement requests and system issues to ensure accurate prioritization and optimal solutions. Promote effective use of enterprise systems across the organization.
  • Lead vendor release management process. Perform release management evaluating scope, impact and prioritization with ongoing activities.
  • Manage all aspects of projects/programs from initiation through closure, including hand-off to Operations when required. Define scope and manage scope expansion; create project plans as necessary to ensure timely completion of projects and goals; address questions, concerns and issues that arise; drive to agreeable resolution; anticipate potential challenges and proactively manage to minimize negative risk.
  • Effectively manage and supervise both contract, vendor and Radius staff in the conduct of Radius business. This can include vendor/budget.
  • Work with IT PMO to follow project management processes.
  • Ensure GxP systems adhere to computer systems validation processes and procedures, including traceability matrix, validation plans and reports for IQ/OQ/PQ and UAT. Partner with key functions (e.g. Compliance, Quality, Legal, Finance, Safety, Human Resources) when appropriate to ensure solutions conform to applicable regulations.
  • Consult on business process design and data utilization, for end to end business processes. As needed map respective business processes (As Is – To Be) and identify efficiency improvements when deploying a technology solution.
  • Manage multiple projects of varying sizes and priorities simultaneously.
  • Work effectively within Radius’ corporate culture, champion partnership among all business groups and IT.

Work Environment:

Ability to travel domestically is required

The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Occasional domestic travel required.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.

Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.



Qualifications

  • 6+ years’ project management experience, showing growth in size and scope of projects.
  • 6+ years’ overall experience in pharmaceutical or biotech industry
  • Work experience with Drug Development solutions such as Regulatory Information Systems, Clinical Data Management, Statistical Analytics
  • 3-5 years’ work experience implementing and/or supporting the following R&D Life Sciences solutions: Veeva Vault, SAS Analytics, EDC
  • Veeva Vault Administrator Certification
  • PMP qualifications desired but not required
  • Experience in all stages of projects, from initiation through deployment.
  • Experience managing projects which engage remote teams and vendors.
  • Ability to work independently with minimal supervision
  • Ability to accomplish results through others, particularly by establishing relationships, effective controls and monitoring processes.
  • Detailed understanding of all requirements for bio/pharma system validation with responsibility to ensure systems are compliant with FDA regulations.
  • Ability to bring resolution to highly complex and challenging situations with multiple constituents.
  • Demonstrated effectiveness in communications including the ability to convey business needs to technical people and to translate and simplify complex technical information for non-technical people.
  • Strong verbal and written communication skills, able to present and interface with users, all levels of management, and external vendors/partners.
  • Strong interpersonal skills with a proven ability to maintain collaborative working relationships with internal business partners, IT team and 3rd party service providers.
  • Demonstrable knowledge of one or more functional areas of Regulatory, Pharmacovigilance, Clinical Data Management, Statistical Programming or Clinical Operations
  • Demonstrable knowledge of the relevant ICH, EU, and FDA guidelines and regulations for clinical trials and post-marketing environments

PM18


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