• Find preferred job with Jobstinger
  • ID
    #46351374
  • Job type
    Permanent
  • Salary
    $140,000 - $175,000 per year
  • Source
    Jobot
  • Date
    2022-10-09
  • Deadline
    2022-12-07

Vacancy expired!

Come join a company that is partnering with researchers on their study designs and support cross-sectional and longitudinal analyses with complex patient inclusion/exclusion sample collection criteria

This Jobot Job is hosted by: Ryan CodyAre you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary: $140,000 - $175,000 per year

A bit about us:

We are accelerating personalized medicine research by empowering patients with their healthcare data and making it as easy as possible for them to participate in the medical research process. We partner with patients and pharmaceutical companies to accelerate precision medicine R&D by securely and efficiently collecting and providing patient samples and relevant health data. We partnered with 20 of the top 40 global pharmaceutical and biotechnology companies to help increase the speed and quality at which they are conducting their research. For the past two years, we received the prestigious designation as a Great Places to Work company. It is an exciting time; our biotech company is growing quickly and needs the best team members to join us.

Why join us?
  • Competitive compensation
  • M/D/V
  • Bonus

Job Details

About:

The senior manager/director level position provides client facing leadership in managing and delivering the operational and financial aspects of multiple translational studies and clinical trial projects from proposal development to final deliverables. These studies range in size and complexity from single service studies to full scope, multiple protocol projects and/or global projects across various phases and functional areas. This role has line management responsibilities and will oversee a dynamic and growing team of Project Coordinators, Project Associates and/or junior Project Managers (PMs). Primary Responsibilities:

  • Responsible for all activities related to implementation of translational and/or clinical studies
  • Responsible for on-budget and/or on-time study completion and compliance with all quality standards and applicable regulations from study start-up, enrollment, maintenance and close-out.
  • Leads a Project Management team to ensure project quality, timelines, and targets/milestones are met or exceed expectations.
  • Owner of the project plan and proposal and regularly liaises with finance to develop, revise, and review study budgets and client invoices. Act as the primary lead for the change order process with clients.
  • Facilitates customer teleconferences and meetings and provides timely deliverables. Responsible for resolving any first level customer escalations.
  • May independently prepare, coordinate, and present project material at internal and external meetings
  • Provides oversight for the development and implementation of study documentation in accordance with the company QMS and study requirements.
  • Directs the activities of assigned Project Support staff; provides line management and mentorship for project management team members as applicable and clinical staff; facilitates team building and communication
  • Oversees interdisciplinary translational and clinical research programs ensuring compliance with ICH/Good Clinical Practices (Google Cloud Platform), relevant Standard Operating Procedures (SOPs) and all other applicable regulations
  • Facilitates staff training and ensure that documentation is completed for internal project teams and provide support for the training for other relevant stakeholders that include the operations team and external vendors as applicable
  • Identifies any potential risks to study timelines and conduct and proactively proposes mitigations and implements plans with cross-functional teams and the client
  • Participates in the review and provides feedback on operational aspects of the study design and feasibility process
  • Coordinates activities and deliverables of all project participants including the operations team and proactively identifies, communicates, and manages issues
  • Prepares regular project management reports and dashboard updates for clients, internal teams, and management
  • Responsible for the maintenance of project information on various databases and systems
  • Works with the Quality team for project management components of audit inspection readiness including Trial Master File (TMF) and customer/CAPA form management. Provides the necessary sign-off for quality forms.
  • Participates in special projects related to operational infrastructure as needed
Skills and Abilities

  • Proven experience managing projects involving multiple agile teams, including internal stakeholders outside your reporting chain and external partners
  • Thorough knowledge and experience in clinical research from Phase I through regulatory submission
  • Ability to manage multiple priorities within a variety of complex clinical trials and translational studies
  • Excellent customer leadership skills; proactively anticipates, understands and responds to the needs of the clients to meet or exceed their expectations
  • Ability to reason with data and logic independently for the purpose of assessing and recommending specific solutions in a clinical operations setting
  • Ability to set baseline targets, track trends, and implement mitigation plans
  • Demonstrated experience or ability to develop dashboards and metrics for Project management function
  • Understanding of basic data processing functions, including electronic data capture
  • Demonstrated problem-solving and financial negotiation skills
  • Working knowledge of current ICH Google Cloud Platform guidelines
  • Knowledge or experience in remote clinical research/trials that involves in-home visits is a plus
  • Experience in a high growth, start-up environment is a plus
Requirements

  • Bachelor's degree
  • 7+ total years experience in project management, program management, or clinical operations in clinical research
  • Certified Clinical Research Professional (CCRP®) or active PMP certification or similar credential is preferred
  • Demonstrated financial management skills required
  • Flexibility and the ability to mentor and manage new staff and to handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment
Technology/Systems Requirements

  • Experience with clinical trial technologies including EDC, CTMS, ePROs and other data platforms commonly used in clinical trials
  • Working knowledge of Word, Excel, and PowerPoint required
  • Experience with Smartsheet & Salesforce preferred but not required
  • G-Suite experience preferred

Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.

Vacancy expired!

Report job

Related Jobs

Jobstinger