My Services

Freelancer in Clinical Operations Management

project-management

Set up and management of clinical studies

Oversight through all study phases (Start-up, Conduct, Close-out)

  • assessment of operational feasibility (eg. country requirements, timelines & budget)
  • set-up & coordinate all necessary activities before First Patient in (FPI)
  • review progress & performance of the study
  • coordination of meetings (internal & external)
  • risk identification & mitigation
  • perform all study close-out activities
agreement

Contracting & vendor management

Drafting, negotiation and execution of contracts with CROs, labs, investigators, service providers, etc

  • non-disclosure agreements
  • service agreements
  • payment agreements
  • vendor management
  • affiliate management
budget

Budget & resource oversight

Overview of budget and payments

  • Fair Market Value Assessment
  • creation of study budget & financial plan
  • overview of payments
  • budget oversight
  • reporting to finance team & upper management
leadership

Leadership of cross-functional teams

Coordination and oversight of program & project activities

  • program coordination
  • timelines management
  • resource allocation
  • stakeholder communication
  • project & program management improvement
Supply Chain Management

Support in Supply Chain Management

Forecasting the demand, packaging and distribution of clinical supplies.

  • Overview of stock levels (initial supply & re-supplies)
  • Support with regulatory aspects, designs & translations of packaging labels
  • drug accountability management, incl. reconciliation of packed drugs, returns & destruction
  • support in sourcing of placebo or comparators
  • expiry date management
Plans

Set up and management of plans

Development of various clinical management plans for study oversight

  • risk management plan
  • site feasibility & selection plan
  • quality plan
  • communication plan
  • data management plan
  • safety monitoring plan
  • regulatory submissions process
  • site management plan
  • laboratory / pharmacy manuals
technical-support

Set up and Management of system tools

Study oversight on various electronic tools

register study on a clincal trial registry (eg. ClinicalTrials.org) & post summary results

  • set-up & maintenance of system for essential study documents (Trial Master File)
  • use of any customer specific tools & systems
Business Process

Development of business processes

Coordination of the development of SOPs and other business processes & documents

  • strong knowledge in ICH-GCP, GMP, GVP, FDA, EMA and other regulatory requirements
  • protocol & amendments
  • Informed Consent Form (ICF)
  • Investigator Broschure (IB)
  • Statistical Analysis Plan (SAP)
  • Case Report Forms (CRF)
  • Final Study Report (FSR)