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Manager, Research Operations Contractor

Cambridge, MA 02139

Posted: 02/08/2024 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 598852 Is job remote?: Yes Country: United States

Job Description

Duties:
  • Work with relevant internal team members from TM, Clinical Development, Clinical Operations, DMPK, Data Management, Quality Assurance, and external vendors to assist in the coordination of sample shipments, data analysis, clinical data transfers, sample/data reconciliation and data review.
  • Monitor and assist in the maintenance and optimization of key clinical patient biomarker molecular profiling and study specimen recordkeeping resources.
  • Assist in authoring and/or reviewing relevant sections of clinical study protocols, laboratory manuals and other relevant study manuals/plans pertaining to the collection, processing, shipment, and storage of clinical study specimens.
  • Working with TM and Clinical Operations team members to initiate and finalize specialty lab vendor contracts/SOWs, manage POs, approve, and archive invoices in support of clinical study objectives and TM biomarker profiling goals.
  • Work with Quality Assurance team members to implement and oversee quality metrics around site performance and compliance, sample processing and data deliverables.
  • Work closely with Clinical Operations team members to align clinical study timelines and deliverables, attending regular meetings as TM support/representative.
  • Support the ongoing development of Discovery-wide operational initiatives including website content maintenance, sample tracking process improvements, and data storage structure planning.
  • Contribute to the strategy and tactics of PO and Contract submission processes for the Discovery organization including data entry, communication, tracking, and efficiency improvements.
  • Participate in Research Operations project development efforts by contributing to information gathering, brainstorming, and tool / process creation.
  • Join TMIR (Translational Medicine and Integrated Research) team meetings and contribute to team discussions and team goals.
Skills:
  • Experience with project management and sample tracking methods and tools such as Smartsheet, Excel, etc.
  • Experience with monitoring clinical study specimen collection, handling, storage, and inventorying a plus.
  • Sample clinical and pre-clinical accessioning experience
  • Experience working with human patient biomarkers and common clinical technologies used for profiling them, including NGS, qPCR, IHC, MSD, NanoString, etc., a plus.
  • Exceptional organizational and recordkeeping skillsets, with strong attention to detail.
  • Strong team player, with good communication skills.
  • Commitment to Core Values: Patients First, Thoughtfulness, Urgency, Trust, Optimism
Education:
  • Bachelor of Science degree.
  • 3-5 years of relevant industry experience, preferably in the Clinical Operations space.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Cambridge, MA

Calling all job seekers! Discover exciting job opportunities in and around Cambridge, Massachusetts, a vibrant city known for its rich history, world-renowned universities like Harvard and MIT, and innovative tech scene. Cambridge offers a unique blend of academic excellence, cultural diversity, and a thriving arts community, with attractions like the iconic Harvard Square, the charming Charles River Esplanade, and the prestigious American Repertory Theater. From savoring local specialties like clam chowder and lobster rolls to cheering on the Red Sox at Fenway Park, there's something for everyone in this dynamic region. Explore job listings today and kick-start your career in this captivating area!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.