Clinical Project Manager

  • location: Sunnyvale, CA
  • type: Temp to Perm
  • salary: $34 - $41 per hour
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job description

Clinical Project Manager

job summary:
General Position Summary/Purposes:

The Senior Clinical Project Assistant provides support to the clinical study teams in the execution of clinical trials. Under the direction of the Clinical Project Associate, CTM or Study Lead, the Sr. CPA's primary responsibilities include maintaining Trial Master File (TMF) and Clinical Trial Management System (CTMS) in an inspection-ready state, assisting with site management, initiating collection of and reviewing and tracking essential documents throughout the life of the trial. This role contributes to the production and distribution of study materials and site/study communications.

This role will be onsite in Sunnyvale.

 
location: Sunnyvale, California
job type: Temporary
salary: $34 - 41 per hour
work hours: 8 to 4
education: Bachelors
 
responsibilities:
Study Planning and Conduct:

  • Assists clinical operation leads in the development, handling, distribution, filing and archiving of essential documents in the TMF
  • Assists and/or contributes to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training material, regulatory document templates, study binders, study plans, study communications and presentations
  • Handles incoming and outgoing clinical trial related materials shipments to site, study team, CRAs and vendors, as needed
  • Facilitates site vendor setup, debarment checks, CDA and site agreement submissions
  • Assists with all aspects of initial study drug release including regulatory packet review and study-drug release
  • Assists clinical study team with the planning, preparation, and on-site support of investigators meetings
  • Assists in the development of case report forms and participate in the EDC and IXRS specification process, as appropriate
  • Communicates directly with sites, Site Management Organizations (SMOs), Contract Research
  • Organizations (CROs) and field CRAs to obtain updated information, essential documents, etc. to assist with driving start-up, study conduct, and/or close out activities
  • Ensures timely study entry and updates to and maintenance of 'Clinicaltrial.gov' until end-of-study under supervision
  • Conduct study tracking support (eg, CTMS tracking, start-up tracking, milestone tracking, close-out tracking) and study updates, as requested
  • Assists with final sign off of project and study-related documents including: informed consent forms, monitoring plans, synopsis, protocols and amendments, and other documents, as required
  • Participates in clinical team activities, including attending required meetings, and interacts in a positive, professional manner. May coordinate meetings/teleconference/WebEx, prepares agendas, minutes, and tracks action items
  • Ensures required corporate training on standard operating procedures, policies, and work instructions are completed by the due date
  • Identifies and escalates issues appropriately
  • Performs other work-related duties as assigned
Qualifications/Core Competencies:

  • Understanding in relevant clinical operations activities
  • Ability to exercise judgment within generally defined practices and policies that lead to methods or processes for obtaining results under supervision
  • Basic knowledge and understanding of ICH/GCP guidelines and FDA regulations required
  • Working knowledge of TMF maintenance and management of essential documents
  • Demonstrates understanding of existing process, SOPs, work instructions (WI) including interest in and supports initiatives as well as communicating areas of inefficiency to team members when identified
  • Solid interpersonal, written and oral communication in a clear, timely, practical manner; actively listens to team members and business partners, asking questions, as appropriate, to confirm understanding and avoid miscommunications
  • Understanding of what assigned tasks are on critical path and uses this knowledge to guide time management and prioritization
  • Demonstrates ability to manage and stay on course with multiple workstreams, including by keeping track of all communications and remaining aware of status, milestones and critical path issues
  • Demonstrates ability and willingness to actively participate and contribute to group efforts
  • Demonstrates willingness to take on additional tasks and assignments when appropriate and takes ownership of and deliver on assigned duties, deadlines, and scope commitments
  • Computer skills including proficiency in the use of Microsoft Word, Excel, PowerPoint, and organization tools
  • SharePoint and filing systems experience is desirable
 
qualifications:
  • 2+ years experience in the pharmaceutical, biotechnology, CRO and/or healthcare setting
  • BA/BS or equivalent degree in a scientific discipline, RN, or related field is preferred but not required
  • Working knowledge of regulatory documents and TMF maintenance
  • Basic understanding of medical terminology and clinical activities in relation to execution of Clinical
  • Development Plan
 
skills: CRF, MS-Powerpoint, Clinical Study Design, CTMS, CTMS (Clinical Trial Management Systems), TMF
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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