Our Client, a global pharmaceutical company, is looking for a Clinical Project Manager who will own the full lifecycle of a sample distribution program, ensuring that all phases from design through delivery are executed on schedule and in compliance with regulatory requirements. This includes developing and maintaining SOPs and PDMA compliance documentation, coordinating the technical implementation of sample-tracking tools in the CRM system, and training the field sales team on proper sampling procedures. The candidate will act as the primary liaison between the client, salesforce presenting project updates and reports.

This is a remote, contractual position, that goes until the end of September 2026, with the likelihood of extension. Candidate's applying for this role must be located in the EST or CST time zones of the USA.

Key Responsibilities

• Oversee the entire physician sampling initiative from defining processes and launching new sample offerings to ongoing distribution and reconciliation. This involves managing logistics and inventory, tracking sample usage, and closing the loop on returned or expired samples.
  
• Oversee coordination between clinical operations, medical affairs, and commercial teams to ensure that sampling programs align with clinical guidelines, therapeutic protocols, and product lifecycle strategies.
  
• Collaborate with clinical data management and medical affairs teams to ensure that any clinical data or insights related to physician sampling programs are properly captured, documented, and aligned with regulatory requirements.
  
• Work with clinical stakeholders and regulatory teams to support audit readiness, ensuring all documentation and sampling processes meet clinical trial support standards and healthcare compliance expectations.
  
• Support cross-functional initiatives between clinical operations, regulatory affairs, and commercial teams when sampling activities relate to product launches, clinical education programs, or therapeutic area expansion.
  
• Contribute to clinical process improvement initiatives, ensuring that digital tools, CRM workflows, and operational processes support both commercial sampling activities and broader clinical engagement strategies.
  
• Draft, update and enforce SOPs and compliance materials (PDMA submission packages, FDA/21 CFR compliance documents, etc.) for all sampling activities. Ensure the program adheres to federal regulations and company policies.
  
• Work closely with IT and technical teams to implement or upgrade the CRM’s sample-tracking module (e.g. Veeva or Salesforce). Validate system configuration, manage user acceptance testing, and ensure the CRM supports audit trails and reporting requirements.
  
• Design and deliver training programs for the sales field team on sampling SOPs and PDMA compliance. Develop training materials and metrics, spearheaded the development of training initiatives that improved compliance to ensure sales reps understand proper procedures and documentation.
  
• Serve as the main point of contact for client teams and physician offices.
  
• Track program performance and prepare regular reports (e.g., monthly/quarterly summaries of sample distribution, inventory levels, and compliance KPIs).
  

Requirements

• 4-5 years’ experience managing pharmaceutical or sales support programs. Demonstrated ability to run a full sample program “from end to end”, including inventory management and sample accounting.
  
• Solid knowledge of FDA/PDMA regulations for drug samples. Proven skill in writing and maintaining SOPs and compliance documents for projects.
  
• Hands-on experience with CRM platforms (e.g. Salesforce, Veeva).
  
• Ability to coordinate with IT and vendors on system configuration and data integration.
  
• Background in pharma or biotech environments, especially commercial operations (sales, marketing, compliance).
  
• Experience working in pharmaceutical, biotech, or clinical research environments, with exposure to clinical operations, medical affairs, or regulatory processes.
  
• Understanding of clinical governance frameworks such as GxP (GCP, GVP, or GMP) and their interaction with commercial and physician engagement programs.
  
• Experience collaborating with clinical stakeholders, regulatory teams, or medical affairs to ensure compliance and operational alignment.
  
• Familiarity with clinical documentation standards, audit preparation, and healthcare regulatory oversight.
  

Preferred Qualifications

• Experience with sample distribution software or electronic sample closets (e.g. Deploy, SampleIQ) and digital sampling strategies.
  
• MBA or advanced degree in life sciences/pharmacy; PMP or Six Sigma/Lean certification.
  
• Exposure to clinical systems integration, including collaboration between CRM platforms and clinical data systems.
  
• Experience supporting clinical-commercial hybrid programs, such as physician education initiatives, product launch support, or clinical engagement tracking.
  
• Background working in regulated healthcare environments where clinical, compliance, and commercial processes intersect.