Project Manager- Clinical Systems

  • location: San Rafael, CA
  • type: Contract
  • salary: $59.50 - $70 per hour
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job description

Project Manager- Clinical Systems

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Internationally known for creating cutting-edge biopharmaceuticals for patients who live with rare genetic diseases, our partner strives to develop critical therapies for the small population - mostly children - that suffer from near unheard of conditions. If you're looking for an exciting opportunity to make a difference with an established company, this is the position for you!

 
location: San Rafael, California
job type: Contract
salary: $59.50 - 70.00 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
The Project Manager for Clinical Systems, Worldwide Research (WWRD), is critical to ensuring successful delivery of technology solutions to meet clinical study goals and objectives.

This position reports into the IM Business Solutions which is responsible for supporting the effective delivery and validation of WWRD's technology solutions through the consistent use of project management practices. The IM Business Solutions team collaborates with all WWRD functions, i.e., Biometrics, Business Technology Management, Clinical Data Management, Clinical Operations, and Medical Affairs to:

  • Identify, define and select technology solutions
  • Manage multiple projects concurrently, maintaining project schedule and quality deliverables in a dynamic environment
  • Manage the technology portfolio to support current and future business needs
The emphasis for this position will be on clinical systems to implement new and amendments to existing IRT's, and other study-specific technology, such as Medidata CTMS, Rave, Coder, ePro. Additional projects and systems, will be assigned as required. The PM will be responsible for assuring alignment with clinical study teams, clinical data management, and other project stakeholders, i.e., Global Strategic Sourcing, external solution providers, regarding project timelines, cost, responsibilities priorities and computer software validation resources internal and external The PM will also partner with IM and QA to govern the system validations, i.e., develop the validation plan, provide risk analysis and contingency planning, and prioritize and manage changes.

The PM is responsible for the full project lifecycle from creation through project implementation including:

  • Provide subject matter expertise on IRT design to meet the protocol requirements
  • Support the User Requirements Specification development, for IRT's work closely with external solution providers responsible for URS development
  • Project plan creation and maintenance
  • Manage project financials
  • Define requirements and scope
  • Project Timeline creation, Task identification and duration
  • Coordination of matrix team resources
  • Facilitate User Acceptance Testing
  • Vendor Management
  • Proactive project communications, status tracking and reporting
  • Ensure all project deliverables are of high quality and exceed client's expectations in compliance with Project Management Office governance procedures
  • Manage communications with internal business partners and external vendors (e.g. IRT, CRO's, clinical systems vendors) and site personnel regarding site/study details
  • Issue and risk identification, mitigation and resolution
The PM works with internal business functional areas, IM, vendors, consultants, and other identified specialists.

 
qualifications:
Education & Qualifications:

  • Strong leadership skills in project definition and delivery
  • Excellent communication and team building skills with an ability to balance, negotiate and work with a variety of internal and external stakeholders to build strategic partnerships.
  • Ability to ensure external vendors are held accountable for delivering to requirements and specifications.
  • Experience with commercial applications that are used in Clinical Operations to support clinical studies within the Pharmaceutical/Biotech industry.
  • Ability to articulate project status in a complete, clear and concise manner, highlighting any risks that require mitigation or issues that require escalation.
 
skills: Other
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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