Planet Pharma
Job Description
Job Description: We are seeking a detail-oriented and collaborative Clinical Supplies Associate, supporting temperature excursion (TE) management and broader clinical supply activities. This role is critical to ensuring the integrity and compliance of clinical trial materials across the supply chain.
Key Responsibilities: • Monitor and assess temperature data for clinical trial shipments and on-site storage. • Collaborate with Quality to evaluate product impact and determine appropriate disposition of materials. • Track and report temperature excursion metrics. • Document temperature excursions in accordance with SOPs and regulatory requirements. • Update the Interactive Response Technology (IRT) system to support resupply shipments. • Coordinate and support investigations related to excursions. • Partner with clinical supply chain, quality assurance, and clinical sites to drive timely resolution. • Assist with additional clinical supply activities, including product destruction, study close-out, and filing documents in the electronic Trial Master File (e-TMF).
Qualifications: Background in pharmaceutical supply chain, cold chain management, or stability management required. Understanding of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). Strong attention to detail and communication skills. Experience working with IRT systems and documentation tools is a plus. 1-3 years minimum experience in related industry.
Bachelor's degree is required.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Job Description: We are seeking a detail-oriented and collaborative Clinical Supplies Associate, supporting temperature excursion (TE) management and broader clinical supply activities. This role is critical to ensuring the integrity and compliance of clinical trial materials across the supply chain.
Key Responsibilities: • Monitor and assess temperature data for clinical trial shipments and on-site storage. • Collaborate with Quality to evaluate product impact and determine appropriate disposition of materials. • Track and report temperature excursion metrics. • Document temperature excursions in accordance with SOPs and regulatory requirements. • Update the Interactive Response Technology (IRT) system to support resupply shipments. • Coordinate and support investigations related to excursions. • Partner with clinical supply chain, quality assurance, and clinical sites to drive timely resolution. • Assist with additional clinical supply activities, including product destruction, study close-out, and filing documents in the electronic Trial Master File (e-TMF).
Qualifications: Background in pharmaceutical supply chain, cold chain management, or stability management required. Understanding of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). Strong attention to detail and communication skills. Experience working with IRT systems and documentation tools is a plus. 1-3 years minimum experience in related industry.
Bachelor's degree is required.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.