Project Manager Job

PROJECT MANAGER NEEDED for a CONTRACT opportunity with Yoh's client located in SOUTH SAN FRANCISCO, CA.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Managing clinical trials
- Knowledge of Clinical Operations and Information systems

WHAT YOU'LL BE DOING:

- Ensures that the clinical systems support the business needs of gRED Clinical Operations
- Serves as a leader for information technology operation in collaboration with IT and business partners
- Accountable to Protocol Execution Teams (PETs) for the delivery of operational clinical systems for effective operations
- Responsible for project management activities related to the deployment of relevant Interactive Voice/Web Response Systems (IxRS) and Electronic Data Capture (EDC) systems
- Acts as the single point-of-contact to PETs and others regarding relevant study systems, UAT, processes and other tools
- Develops and maintains standard project timelines for study-specific systems set-up, UAT and maintenance and closeout
- Partners with PETs and others in TPS to ensure appropriate set-up of systems, including UAT, based on current study needs
- Coaching others in activities related to system's set-up, UAT and ongoing maintenance
- Ensures prompt resolution of critical issues and provides timely and accurate responses to users and others relating to system best practices and regulatory compliance
- Responsible for the clinical ecosystem working as expected prior to releasing clinical study team to global system support help desk
- Serves as first line of contact for all support requests through system go live for each clinical study. Systems include: CTMS, IxRS, EDC, CLARA, CRO clinical systems
- Reports into gRED ClinOps Senior Manager Systems Operations
- Partners with gRED Business Information Management team in providing input to current state that can be addressed by internal committees
- Participates on system related projects with internal gRED ClinOps stakeholders, company's system stakeholders, and gRED ClinOps preferred CRO partners to ensure: (1) operations, (2) data availability and (3) data integrity to the information which is used to manage gRED ClinOps business

WHAT YOU NEED TO BRING TO THE TABLE:

- Knowledgeable with the processes and principles of project management
- Experience managing third party vendors in delivering service as expected through contracting process and support organizations
- Up-to-date knowledge of Clinical Operations and Information systems such as CTMS, IxRS, EDC, Planisware, and Clinical Supply Systems
- Ability to see the interrelationship of systems and procedures within a project and understand their interdependencies
- Broad knowledge of applied GxP experience in pharmaceutical or Biotech industry with clinical drug development experience
- Previous experience in clinical trial planning and execution preferred
- Ability to successfully lead a sub-team or change initiative through implementation with little or no oversight
- Demonstrated ability to function independently with a proactive, self-starter attitude
- Ability to drive results to successful completion
- Analytical problem solving skills to enable ability to define problem statement clearly and accurately and apply structured and disciplined methodology to identify root-causes
- Highly proficient in MS Excel, MS Project
- Highly effective verbal & written communication skills
- Highly effective team player and interpersonal skills (globally, internal and externally)
- Strong customer focus

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- Bachelors degree (MBA or advanced degree preferred)
- 7+ years experience in Biotech/Pharmaceutical industry
- 5+ years experience managing clinical trials is preferred

RECRUITER: Mary Nguyen

Yoh, a DayJ2W:CLINICAL

TAX TERM: CON_W2J2WPACNW

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