Job Description: The Clinical Systems Analyst role supports activities pertaining to data strategy, systems, reporting and analytics in Global Clinical Operations (GCO). This includes supporting a wide range of dashboard development, running of recurring reports, ad-hoc analyses and oversight of operational data quality, as well as key processes related to data capture/output in clinical trial...

The Organizational Change Manager is part of the Global IT Portfolio Management & Governance organization. The Organizational Change Manager will focus on the people side of change, including changes to business processes, systems, and technologies associated with the Requisition-to-Pay Transformation project. You’ll execute the change management plan to help employees maximize the adoption of...

Senior Clinical Study Manager Pharmica seeks a Senior Clinical Study Manager to lead the start-up and management of a large Phase III Pediatric Gene Therapy trial, for our client in the San Francisco, CA.   Description: The Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting into the Senior Director, Clinical Operations. This position may require the...

Senior CMC Product Manager Pharmica is seeking a Sr. CMC Product Manager to help drive the overall success of development & commercial programs within Manufacturing & Technical Operations at our client site in South San Francisco. Responsibilities · Work collaboratively with the Technical Leads and CMC Sub-teams to plan, track and report the diverse activities managed by Manufacturing &...

The Clinical Trial Manager (CTM) will lead the planning and manage the implementation of early and late phase clinical research studies, including creating and managing study timelines, budgets and study management plans in a fully outsourced model. This role provides oversight of Clinical Research Organizations (CROs) and other vendors and may author, review and approve various study related...

Pharmica seeks a Clinical Contracts Associate to help with the management of Site Contracts at our client’s site in the Foster City, CA. Assignment Position will be accountable for the drafting, negotiation, and review of global Phase I through IV clinical investigative site and related ancillary contracts (together referred to as “site contracts”) including both language and budget, the...

Project Manager Consultant – Process Intelligence and Data Historian Delivers project management support and oversight for the Process Intelligence System and Data Historian (OSI PI) Projects, which involves the implementation of a Process Intelligence system, Data Historian application, and all other projects as needed by the business.This includes the all work associated with the RFI and...

As part of an overall cross functional Software Development Lifecycle (SDLC) approach to computer systems compliance and validation, the CSV consultant will be involved in all aspects of computer systems validation and qualification within a GxP regulated environment. Following policies and procedures for CSV, the CSV consultant will be involved in the overall development and maintenance of GxP...

The PV PM will work on the Pharmacovigilance team and support the team on projects. Job requirements:  Analysis of Compliance Metrics to determine operational improvement ideas Global PV Leadership Team (GPVLT), GPVLT IT, GPVLT leadership and support Finance and budgeting for PV ICSR (individual case study reports) QC Checklist Data Archive Global PV Product Roster Maintenance and...

Duties: Case Processing: Interacts with vendors, CROs, and partners on a daily and as-needed basis. Escalates issues and develops resource strategy with senior management. Vendor Case Management: Lead for PV CRO/vendor projects and ongoing management oversight. Monitors CRO/vendor reports (daily, weekly, monthly as required by project) to ensure quality completion of deliverables.Responds to...

Field Based Remote Position - Home office based (Travel: 30%). Ideally this person would live near a major airport for travel requirements. The Project Manager Country Operations (PMCO) is responsible for the successful execution of study deliverables and the quality execution of protocol procedures, adherence to good clinical practices (GCP) and evolving regulatory requirements, and ensure...

The R&D Quality (RDQ) Management System/Electronic Document Management System (eDMS) Lead will manage the key process and system changes within RDQ that assures R&D employees perform their work in a consistent, high quality manner. This involves providing strong Process and Technical skills to drive implementation of both our Quality Management System (Procedural Document, Training, Audit,...

Job Description: This position involves documenting processes, activities, check lists, user manuals and other documentation for all phases of Drug Development projects. The position involves collaborating with and supporting the Process Owners as well as Process Teams to evaluate documentation requirements, identify operating procedures, and create necessary procedural documentation. The...

Data Sciences Coordinator/Project Manager   Job Description: Supports Head of Data Science in preparation of Data Governance Council meetings Ensures all Domain Leads are up to date on all policies and decisions coming out of the Council Facilitates conversations between Domain Leads to share best practices across R&D On-boards Domain Leads to relevant tools and processes Provide PM...

We are looking for an additional part-time consultant that can assist the non-clinical team with their inspection readiness activities. The consultant should be able to assist with the following: Work with Bioanalytics, Bioinformatics, and Pharm Tox to identify relevant documents/data/reports to fulfill BIMO checklist in support of a pre-approval inspection Create an archive with these...

Pharmica is seeking a Launch Project Manager to support our client, in Northern New Jersey, with the US launch of a product line extension.This is a part-time,12-month contract position, requiring approximately 20 hours/week, through Dec 2020. The hours may be increased according to need. Job Requirements: Breadth of experience managing key “Launch minus 1 year” activities in Regulatory,...

Job Description The Argus Project Manager acts as a central contact for information on Argus related projects.The project manager ensures concurrence between team members and management is achieved for project objectives and meets these objectives to achieve goals. Works with management staff and teams to create the project strategy, establish objectives, and monitor team progress. Makes...

Project Manager is responsible for developing and managing a newly proposed clinical trial Patient Portal Project inclusive of cost, time and scope. Key activities will include developing and maintaining project plan, communication plan, issues/risks log along with allocating tasks, setting milestones, and collaborations with multi-stakeholders and vendor. Responsibilities: Using project...

The Product Quality Lead (PQL) is to provide quality oversight of new device and combination clinical and commercial products from introduction throughout the product and design control lifecycle. As the product quality expert, the PQL will build the strategy to proactively minimize product quality and design control risks through early detection and mitigation during product development,...

A Principal Clinical Data Manager (PCDM) has a keen attention for detail and is responsible for overseeing the start-up and execution of several trials with a CRO or in-house to ensure data quality and integrity. PCDMs will independently lead multiple, high volume and extremely complex studies within a development program. The individual will perform a variety of complex tasks to ensure complete...

The Project Manager must generally be steeped in the business of drug development with the ability to take on work from the client team and advance agreed upon deliverables with a high degree of independence.They must be comfortable working with teams and articulate both verbally and in written communications. MS Project is the key medium by which timelines are developed and any candidate must...

The position is in the Global Quality Enterprise GxP e-Systems department within the Data Integrity Governance group and is responsible for driving the implementation of an effective GxP Data Integrity Governance Program (the Program) across the end-to-end (R&D, Operations and Supply Chain) product lifecycle to ensure that regulatory and requirements are addressed in a thorough effective, and...

Job Description The Drug Development Project Manager acts as a central contact for information on a particular program and manages activities to develop programs. Ensures that concurrence between the team and management is achieved for program objectives and meets these objectives to achieve goals. Works with management staff and teams to create the development strategy, establish objectives,...

Duties: Clinical Project Lead (CPL) is responsible for and manages study deliverables through internal and external resources and is the primary point of contact and interface between these functional groups, investigator sites and vendors. Direct the execution of clinical trial activities in accordance with Client SOPs, ICH Guidelines, and Good Clinical Practice (GCP). Ensure compliance of...