Outsourcing Manager/BioMarker Operations Manager


Bridgewater, New Jersey

a month ago

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Outsourcing Manager/BioMarker Operations Manager
Bridgewater, New Jersey

a month ago

Job Description

Job Title: Outsourcing Manager/BioMarker Operations Manager
Location: Bridgewater, NJ 08807 (Hybrid schedule, 2 days onsite, manager is flexible on which two days are onsite but may also need the candidate to be flexible if there is a special need to change the day.)
Duration: 6 months

HM Notes:
  • Person will interact with internal scientists/lab and external vendors/labs.
  • Ensuring vendors are in client's system and if not, get them into the system by working with Legal Dept.
  • Will generate Purchase Orders and schedule experiments.
  • Must have Bioanalytical experience so they can help lab troubleshoot issues when applicable, Outsourcing experience preferred but the major focus/must haves should be at least 5 years (with masters or higher degree) or 10 years (with bachelors degree) bioanalytical experience, regulated experience, experience supporting clinical studies, biomarker ops or analysis.
  • MUST BE 5 years Pharma industry or 10 year pharma industry depending on level of degree.
  • Degree should be in bio, science, or chemistry.
  • Needs strong communication and project management skills.
  • Will have multiple projects going at the same time.
  • Manager does not care for their research experience.
  • Experience counted must be clinical.
  • Start ASAP.
  • Strong possibility for extensions.
Work Schedule  
9-5 EST, Mon-Fri

Act as the project manager to support the externalization and operationalization of clinical biomarkers and bioanalytical activities for pre-clinical and clinical drug development.
• Support the team on budget predictions, management and tracking for a clear understanding of the biomarker operations and their impact on the project.
• Be the key point of contact for biomarker activities whether they are managed externally or internally to inform the team to make data driven decisions.
• Oversee PK or ADA bioanalysis that is performed externally.
• Identify and help onboard vendors for specific analysis, provide advice and support on scientific and technical aspects of analysis where possible.
• Interact closely with Translational Medicine (TM) subteams to execute biomarker plans for clinical studies.
• Monitor assay development, assay validation and sample analysis processes, ensure timely delivery of quality results in compliance with regulatory guidance.
• Support final data import.
• Interface with Central Labs and sample management team to ensure the sample logistics meet study requirements.
• Work collaboratively with the CROs, ensure that all studies are managed in respect to timelines, budget, scientific integrity, and quality deliverables.
• Assure all aspects necessary for contracting studies are in place. This includes developing and maintaining a strong working relationship with Procurement, Legal and other support functions to provide RFP (Requests for proposal/information), Legal Contracts, etc..
• Collaborate with Quality Assurance to establish and perform audits and ensure that selected CROs respect the quality assumed by client. 

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $70.00/hr.