ECOA Project Manager

Hiring By - Biostaffic

 BioPharma

Job Highlights

Not Disclosed

Entry level

Posted 4 months ago
Job details
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
eCOA Project Manager
Home Based position in the US or Canada
We are seeking a highly organized and experienced eCOA Project Manager to oversee the efficient execution of electronic Clinical Outcome Assessment (eCOA) projects at Fortrea. Within the FSP model, this sponsor dedicated eCOA Project Manager is accountable for the client’s study specific eCOA system implementation, ongoing conduct support, closeout and decommission. The ideal candidate would possess a strong background in project management, have experience successfully managing a collaborative client relationship and serving as the lead on eCOA projects. Experience with wearables and eClinical systems will be considered a significant advantage. This is a permanent, full time role.
The eCOA Project Manager is accountable for the client’s study specific eCOA system implementation, ongoing conduct support, closeout and decommission. Provides subject matter expertise, leads study specific implementation, ensures on time delivery, and remediation of support issues.
Position Summary:
Lead the development and implementation of solutions to global technical services issues and concerns regarding EDC tools like Medidata RAVE or Oracle Inform or Data/Report programming or Visual Analytics tools like Spotfire or Tableau.
Develop/validate Custom/Complex SAS / SDTM datasets and efficiently handle external data and reconciliations.
Perform any postproduction changes to the EDC database or enhancements to the SAS programs like SAS edit checks, listings, Protocol Deviations, SAS Datasets etc., Conduct Peer Review/Quality control of study design for assigned projects.
Main Responsibilities:
  • Oversee outsourced eCOA systems that are implemented within a trial
  • Proactive follow-up with Sponsor and Third Party Vendor to ensure comprehensive understanding of study design and technology design (Involve a kick-off meeting with various stakeholders) with a view to providing quality deliverables.
  • Involvement from Creation of the Request for Proposal up to Creation of the User Acceptance Testing (UAT) Plan, directing the execution of the test scripts, manage defect tracker leading eventually to System Go-Live.
Same responsibilities, post production release. Deliverables include but not limited to:
  • Coordinating the review and approval of Sponsor and Third Party Vendor generated documents (Business Requirement Documents, Configuration specs, Project Management Plan, UAT Plan, Study Manuals and Guides)
  • Tracking of documentation
  • Maintenance of the TMF for Sponsor related documentation
  • Adherence to Clinical Planning timelines for System release and any subsequent change controls / amendments and risk assessments
  • Representing as eCOA SME for the Sponsor on Clinical Study Team and Design meetings
  • Respond to and solve technical oriented problems as appropriate
  • Coordinating with all stakeholders during the maintenance phase and provide update to Sponsor teams via regular meetings with Third Party Vendor PM
  • Assist Sponsor team members with data transfers, EDC Integrations, Data Clarification / Change Forms
  • Coordinate and assist Sponsor teams during close out phase with decommissioning, document archival and eTMF reconciliation.
Minimum Qualifications:
  • University / college degree (life sciences, health sciences, information technology or related subjects preferred).
  • Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor’s degree.
  • Fluent in English, both written and verbal.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience Required:
  • 5 to 8 years of relevant work experience to include data management and database support.
  • Good oral and written communication skills.
  • SAS Programming or Spotfire or Tableau development.
  • Good problem-solving skills and a proactive approach.
  • Basic knowledge of clinical trial process and data management, biometrics, and systems applications to support operations preferred.
  • Demonstrated ability to work in a team environment.
  • Demonstrated ability to work independently under supervision.
  • Proven interpersonal skills.
US Pay Range: $90,000 - $130,000 USD
Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. For more detailed information, please click here.
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
The job application deadline is March 4, 2024.
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data, please see our Privacy Statement.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

Experience:

  • Entry level

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 14, 2024
Company Overview
Fortrea
Fortrea

Current Openings: 0

Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team of approximately 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.
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