IT Project Manager Lab SystemsApply Now
Location: Waltham, Massachusetts 02451
Employment Type: Contract
IT Project Manager (Clinical/Regulatory), Onsite in Waltham
- Seeking a seasoned IT Project Manager with a strong background in the Clinical and/or Regulatory area.
- You will lead and manage software implementation projects related to business and systems initiatives within the clinical space.
- Data Lake or cloud-based project experience preferred
- You will work closely with all internal groups and external third-party service providers to establish project plans which consider critical tasks, durations and dependencies.
- You will be expected to be autonomous in management of meetings, solicitation of agendas, distribution of meeting minutes, tracking completion of action items and regular updates on project status.
- Manage projects using project management best practices and following required SDLC policies
- Elicit requirements using interviews and workshops, document analysis and business process descriptions, use cases, scenarios, business analysis, task and workflow analysis
- Create and distribute documentation as needed: Functional Requirements, Business Requirements, Use Cases and End-to-End testing documents, Data Flow Diagrams
- Serve as the conduit between the customer community (internal and external customers) and the software development team (external vendors)
- Build and foster effective relationships between the business and IT and oversee vendor relationships
- Introduce best practice and process improvement ideas and ensure adherence to FDA computer systems validation compliance
- 5+ years of pharmaceutical/biotech industry experience is MUST
- Proven track record to lead a small-to-mid-sized team
- Enterprise information management systems and software vendor selection
- Demonstrated ability to manage several complex projects at the same time
- Experience working with third-party implementers
- PMI or equivalent certification preferred
- Managing cloud/SaaS based application implementations
- Domain knowledge of clinical/regulatory requirements/guidance/compliance areas (e.g. eTMF, ICH guidelines, GCP regulations) preferred.
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