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Manager, Research Operations Contractor
45 Sidney Street Cambridge, MA 02139 US
Job Description
- 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.
- 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
- Bachelor of Science degree.
- 3-5 years of relevant industry experience, preferably in the Clinical Operations space.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The 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, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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