The Program Data Management Lead is a strategic leader responsible for the overall management of Programs in Clinical Data Management (CDM). This individual oversees data management activities, including quality, timelines, and resources related to clinical research studies. They ensure compliance with regulations, such as ICH/GCP and company Standard Operating Procedures (SOPs), within assigned programs.
Key Responsibilities
Maintain an overview of clinical program status and issues, communicating progress, risks, and changes that impact quality, timelines, and budget. Review plans and provide CDM expertise during protocol design, study start-up, and conduct phases. Ensure consistency within the program and develop standard methodologies within CDM. Oversee CDM study budgets, reviewing initial budgets and handling budget changes throughout the program lifecycle. Requirements
Bachelor's degree in Mathematics, Science, or a related field. Minimum 12 years of clinical data management experience in biotechnology, pharmaceutical, or health-related industries. The successful candidate will possess excellent leadership, communication, and problem-solving skills, with the ability to manage multiple projects and prioritize tasks effectively. A strong understanding of CDM principles, regulations, and industry standards is essential. This role requires a professional who can work independently and collaboratively as part of a global team. The ideal candidate will be able to adapt to changing priorities and deadlines, with a focus on delivering high-quality results.
Maintain an overview of clinical program status and issues, communicating progress, risks, and changes that impact quality, timelines, and budget. Review plans and provide CDM expertise during protocol design, study start-up, and conduct phases. Ensure consistency within the program and develop standard methodologies within CDM. Oversee CDM study budgets, reviewing initial budgets and handling budget changes throughout the program lifecycle. Requirements
Bachelor's degree in Mathematics, Science, or a related field. Minimum 12 years of clinical data management experience in biotechnology, pharmaceutical, or health-related industries. The successful candidate will possess excellent leadership, communication, and problem-solving skills, with the ability to manage multiple projects and prioritize tasks effectively. A strong understanding of CDM principles, regulations, and industry standards is essential. This role requires a professional who can work independently and collaboratively as part of a global team. The ideal candidate will be able to adapt to changing priorities and deadlines, with a focus on delivering high-quality results.
