Biotech/

Pharmaceuticals

  • Clinical Development Plan Design (Phase I – IV)

  • Program Resource

  • Planning & Budgeting

  • Cross-Functional Asset Development

  • Clinical Development Teams

  • Strategic Program Planning & Resourcing

  • Asset Pipeline & Lifecycle Management

  • CDP Risk Management & Mitigation 

  • Translational Development Transition & Management

  • Laboratory Information Management System (LIMS)

  • Clinical Project Management Phase I – IV  

  • Study & Site Management 

  • CRO & Vendor Selection & Management

  • Site Contracts & Budgets

  • Site Monitoring

  • SOP Development & Compliance

  • TMF Management

  • Project Budget Analytics

  • Clinical Staff Coaching & Mentoring 

  • High Performing Functional Leads

  • Competitive Intelligence & Metrics (Dashboards)

  • Laboratory Information Management System (LIMS)

  • Quality Management Systems

  • QA SOP Development

  • Site & Vendor Qualification & Auditing (GCP, GLP, CLIA Accreditation)

  • Internal Sponsor SOP Audits

  • Process Deviation & CAPA Management

  • Harmonization & Validation

  • Sponsor & Regulatory Inspection Readiness

  • Manufacturing Oversight (GMP)

  • Computer Systems Validation

  • Document Quality Assurance

  • CSR & Clinical Protocols

  • Publications & Manuscripts

  • Regulatory Documents (CMC, clinical & non-clinical)

  • Document Development SOPs

  • Submission Document Management

  • Project Management

  • Data Management Plan

  • CRF Designing

  • Customized Database Design, Screen Testing & Development

  • Edit, Validation and Design check programming, UAT

  • Data Validation

  • Data Cleaning

  • Local Lab Data Management

  • Patient Diary Data Management

  • Serious Adverse Event (SAE) Reconciliation

  • Manual / SAS® Data Listings Review

  • Quality Control – Sample QC & Critical QC and Data Quality Audits

  • Database Soft & Hard Lock and Export to SAS®

  • Health Economics & Outcomes Research (HEOR)

  • Medical Information 

  • Medical Communications 

  • Portfolio & Asset Lifecycle Management

  • Study Design (Phase IV & Registry Studies)

  • Early Phase Indication, Epidemiology & Patient Assessment

  • Clinical & Marketed Case Safety Reports

  • Region Specific & Aggregated Safety Reports

  • Scientific Literature Surveillance

  • Safety Signal Recognition & Analysis

  • Safety Risk Management

  • International Asset Registration & Licensing  

  • Technology Transfer & Asset Integration  

  • Label Development & Review

  • Regulatory Operations Support

  • Regulatory Project Management

  • Regulatory Activity SOP Development 

  • FDA & EU (483 Observations, Warning Letters, Consent Decrees) Remediation

  • Program & Project Planning

  • Resource Allocation & Management

  • Budget Establishment, Analysis & Tracking

  • Project Scope Definition

  • Coach, Mentor & Train others PMs

  • Functional Leaders & Team Members

  • Success Measures & Metrics (Dashboards)

  • Assessments

  • PMO & PPM

  • Operations & Manufacturing Strategy 

  • Process Development

  • Technical Transfer

  • Innovation & Product Development

  • Sourcing & Procurement

  • Integrated Planning & Analytics

  • Supplier Compliance

  • Contract Manufacturing Oversight

  • Quality Management System (QMS)

  • Baseline or Gap Assessment

  • Inspection Readiness

  • GMP, GCP, GLP

  • Supplier/Distributor

  • Contract Manufacturer

  • ISO 9001

  • 21 CFR Part 210 & 211

  • 21 CFR Part 11

  • Auditor Training

312.424.0500
205 W. Wacker Drive, Suite 515, Chicago IL 60606
  • White LinkedIn Icon
  • White Instagram Icon
  • White Twitter Icon
  • White Facebook Icon
  • YouTube

Copyright © 2016    GForce Employment Professionals, LLC    All Rights Reserved     www.gforcelifesciences.com