Intrinsic Clinical Systems is a SaaS provider of cloud-based software products – CTMS, Site Feasibility & Engagement, Resource Management, and Time Tracking. Our tools help biopharma companies more easily manage their trials, resources, and sites, using today’s latest technologies. Intrinsic works closely with system owners and end users around the world to implement, integrate, and customize...

Roles/Responsibilities: Develop an in-depth understanding of the contingent workforce strategy. Partner with Financial Planning and Analysis, Strategic Sourcing, Legal and other Business Partners to ensure a robust understanding of the Contingent Workforce ecosystem across the client. Consult and advise on contingent workforce process. This will include overall strategy, quarterly and...

Job Responsibilities  Develop and implement quality management plan for the program Interpret key metrics and provide the information to the Global Product Team Leader and cross-functional development team members Support GCP SOP development and serve as a quality operations reviewer Execute client's risk-based methodologies for the planning and execution of clinical protocols. Manage quality...

Execute on and continuously influence overarching project strategy and roadmap. Lead change management efforts associated with core organizational changes, inclusive of defining strategy for execution, stakeholder engagement, and adoption measurement. Able to facilitate whiteboarding sessions with project stakeholders and synthesize outputs. Document change impacts and define mitigation...

Duties: A Submission Process Remediation Project Business Process Analyst is required to re-mediate a Regulatory Operations submission process issue and provide recommendations to ensure the problem does not reoccur in the future. Daiichi Sankyo utilizes CROs to provide regulatory submission services for developmental and commercial applications. The CROs may, at times, either directly author...

This role requires 3-5 years of process modeling, system requirements definition experience and working with cross-functional stakeholders. Demonstrated experience working within the pharmaceutical industry is required. Experience in Regulatory Affairs and Regulatory Information Management is strongly desired. Excellent presentation and communication skills (verbal and written). The candidate...

Need a Junior eTMF/Study Document Assistant to upload & tag sponsor study documents into eTMF 1-3 years’ experience QC CRO uploaded site documents They will be using Medidata eTMF but experience with this system is not required 20-25 hours/week and remote 6-9-month contract, in preparation for filing in 2020

Need an eTMF Manager to oversee and ensure proper uploading and tagging of study documents in eTMF Must have 3+ years of experience working with eTMF and study document management Direct and manage eTMF assistant, who will doing the bulk of the uploading Provide guidance and assistance with document tagging Coordinate and work with stakeholders & CRO Manage overall workload, ensure...

The Project Manager will lead the cross-functional implementation team for a new time tracking tool that will also be leveraged to improve R&D tax credit calculations, inter-company cross-charges and time-off request/approval. This is a multi-wave implementation, with the first roll-out targeted for 2019 year-end for US R&D employees. The cross-functional team will consist of business partners...

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,...

Support daily activities related to processing and maintenance of controlled GMP documents associated with document management functions(procedures, specifications, reports and batch records). Support activities related to the processing of training records associated with the training program by creating courses in electronic training system. Assist with the development and implementation of...

Pharmica is looking for a Pharmacovigilance Specialist to provide vendor oversight and case processing support in Princeton, NJ. This person will be responsible for QCing vendor entries into the ARISg database, confirming that all cases are properly coded, and resolving any errors/issues in a timely manner. Candidates must have at least three years of PV experience. Experience with ArisG is...

Pharmica Consulting is looking for a SharePoint Project Manager.  Description Meet with functional stakeholders to understand process improvement opportunities Use SharePoint and the Microsoft stack to implement process improvement projects Collect requirements, develop prototypes, review prototypes, make recommendations to team Implement projects by emphasizing best practices, training,...

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...

Duties: Use deep process knowledge and experience to assist business partners with the creation, review, approval and closure of deviations, investigations, CAPAs, change controls and associated quality risk assessments in compliance with internal and external requirements. Proactively identify opportunities and support continuous improvement of enterprise QMS processes and associated systems....

SharePoint Change Management Consultant Assist with portal redesigns: Redesign content focusing on the top things a user needs to know Use SharePoint Online Modern Experience; Reformat blog postings to modern Shift focus on better practices & getting started tips for products and scenarios Relaunch of both portals using appropriate communication channels and change agent community   ...

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...

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,...

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,...

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...

Project Manager Consultant – MES Delivers project management support and oversight for Manufacturing Execution System (MES) Projects, which involves the implementation of the MES system for electronic logbooks and all other projects as needed by the business.This includes the all work associated with the RFI and RFP processes, requirements definition, configuration, validation, cutover to...

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,...

The project coordinator is responsible for project management, roadmaps, analysis, communication and documentation, reporting, budgeting and other tasks.   ROADMAPS: Partner across business teams to sustain the PSE JJOS deployment roadmap in CASCADE tool ANALSYSIS: Adhoc, Excel based analysis (trending, paretos, pivot tables, etc.) of process data (inventory levels, cycle times, failure modes...

QMS-LMS-DMS Implementation Business Analyst  Provide implementation support for Quality Management System, Learning Management System and Document Management System Partner with the Quality team to clearly document business requirements Engage with additional stakeholders in Quality Assurance to identify and understand their requirements Model current and to-be business processes with...

Pharmica is seeking a Medical Affairs Project Manager. Responsibilities: Partners with US Medical Affairs Oncology and stakeholders to manage the creation of the Medical Strategy and Objectives Collaborates with functional owners in Medical Affairs to define and maintain a detailed project plan in alignment with overall Medical Strategy and Objectives Reports the progress of Medical...

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...

The Clinical Trial Transparency lead will be an expert on listing clinical trial protocol and trial results on public websites (ClinicalTrials.gov, EudraCT, EU PASS, Germany and company webpage). As the CTT lead, he/she will oversee all work outsourced to the vendor and is responsible for ensuring compliance with legal/regulatory requirements (e.g. US Final Rule) and industry commitments (e.g....

Project Manager is responsible for developing a true project management capability within the client's study management group Responsibilities: Manage overall project plan and lead project team. The end goal of the project is to ensure that studies are managed using a true project management framework, including tools and templates to facilitate standardized and consistent study management ...