Manager, Scientific Operations II
211 Mount Airy Rd Basking Ridge, NJ 07920 US
Job Description
Target Pay Rate: 35-50/hr **salary will be commensurate with experience
Job Summary:
The position of Manager Scientific Operation, Precision Medicine (PrM) will be responsible for managing a broad spectrum of PrM scientific operation activities, including but not limited to contracting (budget forecast, contract execution and invoice inquiry resolution, etc.), project management and coordination of PrM sub-team activities and regulatory submission deliverables, PrM regulatory documentation management, liaison with internal and external partners and provide project management and technically-associated logistic support for clinical bioanalysis and biomarker tasks, identify scientific operation improvement opportunities and drive cross-functional process improvement initiatives.
Responsibilities:
- Collaborates with Outsourcing, Finance, Purchasing and vendors to execute contracts and amendments, resolve invoice queries, generate budget estimation and support PO tracking activities.
- Applies project management disciplines to organize, formulate and execute timelines for PrM projects including regulatory submission activities with high degree of independency.
- Facilitate and manage interaction and alignment with cross departmental and external stakeholders to accomplish critical PrM project goals.
- Coordinate PrM project team/sub-team activities. Manages memberships, facilitates meetings to assemble study deliverables at multiple decision points in the Global Drug Development Process and authors meeting summary across multiple PrM sub teams.
- Performs document management support for PrM submission activities - drives review and approval workflow in partnership with Medical Writing and Publishing teams, manages PrM documents on shared drive to support submissions.
- Identifies opportunities and recommends strategies for scientific operations process improvement that promote efficient collaboration of PrM with other internal and external collaborating partners
- Provides Scientific Operational Support for the Clinical Bioanalysis and Translational Biomarker teams including study management support across multiple programs.
- Applies project management discipline to establish and implement clinical bioanalysis timelines, oversight of vendor and project deliverables and manages study logistics including sample tracking and reconciliation.
- Act as the functional point contact for coordinating vendor access requests to DS data and documentation repository systems.
- Leads the task of establishing study-specific work procedure for reporting Anti-Drug Antibody data from bioanalytical lab to clinical sites.
- Coordination and liaise multiple stakeholders to maintain ongoing ADA sample results tracking, which is needed for clinical study subject follow up visits decision making.
Skills:
4+ years working in the pharma industry required
1+ years working experience in global drug development organization preferred
1+ years working experience in managing contracting activities is strongly desired
Project management experience. Fluent use of Microsoft Project to create Gantt charts is expected.
Experience with GxP, TMF and Submission Vault system
Education:
Bachelors degree in Science, engineering, or healthcare administration required
Masters degree preferred
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