Pharm-Olam, LLC

Project Specialist (Mexico)

Job Locations MX | BR
Job ID
2021-2989
Category
Clinical Operations

Why Pharm-Olam

Pharm-Olam, LLC is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package.

This is Important Work

Project Specialists provide support to project management to deliver projects within the established budget and timeline. Typical duties include coordination of project activities through collaboration with project team members, dissemination of project information and guidance to ensure adequate support for the study team, preparation of agendas for meetings, documenting key decisions and providing relevant updates as needed. They write and disseminate work plans and project documents, including procedures, progress reports and presentations.

In collaboration with Project Managers, Project Specialists communicate effectively in both oral and written forms to a variety of stakeholders (Sponsors, Vendors, Pharm-Olam study teams) to achieve study goals. They contribute to planning and decision making and liaise with project stakeholders to collect and disseminate project information. #LI-REMOTE

Your Role

Provides continuous support to Project Managers (PM), Clinical Trial Leaders (CTL) and study team throughout the course of the clinical trial. Daily support includes, but is not limited to:

  • Preparation and maintenance of study trackers
  • Attendance to the study teleconferences, preparation of TC minutes and tracking TC minutes in CTMS
  • Attendance to F2F meetings (KoM, IM)
  • Planning and attendance of handover meetings for the CTAs who are joining/leaving the study. Reviews HO form and signs off as Transfer Chair, as needed.
  • Submission and tracking of access requests for the Pharm-Olam study team
  • Adaptation of default folders on ePOI Cloud / Active studies for working documents to facilitate study needs
  • Creation and maintenance of Global Contact List
  • Creation and maintenance of Trial Responsibilities Log for Pharm-Olam study team.
  • Upload and assignment of trainings in QPulse for the study team. Follow-up with study team on training completions.
  • Creation of Project Specific Training Matrix and its upload to QPulse.
  • Creation of study specific Correspondence Management Plan
  • Sorting out Public Folders for study level and usually Vendors and Sponsor correspondence
  • Follow-up and reminders to the study team to sort out Public Folders regularly and escalating backlogs to PM in a timely manner
  • Review reports in CTMS to ensure completeness, consistency and information is up to date prior to their distribution
  • Generation and distribution of daily or weekly reports from various systems
  • Follow-up with CRAs for CTMS updates if data is missing for reports.
  • Customization and distribution of study logs/forms templates
  • Organization of centralized printing for study material
  • Support with centralized IMP/lab kits distribution
  • Supporting CTAs with study related questions/issues.
  • Submission of trial level documents to Veeva Vault eTMF Document Inbox. Resolving rejections.
  • Working with TMFL on reconciliation of TMF Trial Level Documents.
  • Pharm-Olam study team CVs reconciliation and follow-up and submission to eTMF.
  • Assistance in preparation of eTMF Plan with the TMFL.
  • Supporting PMs during audits/inspections. In cooperation with QA/Compliance follow-up on open items/cases in QPulse and delegation to responsible parties for resolution. Ensuring all resolutions are provided to the PM /Sponsor within given timelines. Following-up with study team to resolve TMF related findings and work with TMFL to ensure documents are provided by the study team for filing in the eTMF.
  • Distribution of Newsletters to the sites and support with formatting, if required
  • Preparation of weekly CTMS project status reporting and distribution to internal study team as a reminder on pending actions
  • Administrative support for DSMB activities for assigned studies.
  • Other administrative ad hoc support to PM not mentioned above.
  • Management of investigator payments in CTMS
  • Entering protocol level milestones in CTMS and conducting monthly reviews to ensure that content is accurate and up to date. Following up with local study teams to ensure country and site level milestones are being updated regularly.
  • Resource requests for team development
  • Support with setting up study Zoom account and organization of study related meetings and webex trainings, as needed

Your Team:

  • Typically reports to Project Specialist Management – Manager or Associate Director
  • Collaborates with project teams and all Pharm-Olam staff
  • Communicates with Sponsor and sub-contractors if requested by Project Manager
  • Collaborates with Training Department

 

Required Education and Qualifications

  • High School Diploma/Certificate or equivalent combination of education, training and experience; Bachelor’s degree or equivalence (BS/BA) preferred
  • Experience of at least 1 year as Senior CTA or within a similar role. CTA III high performers may qualify for PS I.
  • Fluency in English (spoken and written)
  • Strong verbal and written communication skills
  • Computer literacy, proficiency in Microsoft Office
  • Excellent interpersonal and organizational skills
  • Ability to work independently and to effectively prioritize tasks
  • Ability to manage multiple tasks within a project or multiple projects
  • Attention to detail
  • Ability to work in an environment that changes rapidly to fit client needs
  • Ability to establish and maintain effective working relationships with co-workers, managers and vendors
  • Excellent management skills in order to successfully train and organize study team, to supervise, prioritize and delegate
  • Ability to meet deadlines
  • Effective problem-solving skills
  • Excellent presentation skills
  • Ability to work remotely with diverse teams

Apply Now

 

Please apply online at www.pharm-olam.com/careers

 

Pharm-Olam, LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

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