Clinical Data Manager
2 days ago
We are seeking a highly skilled Clinical Data Manager to join our dynamic team at Digital Prospectors. As a key member of our Data Management team, you will play a vital role in ensuring the integrity and compliance of clinical data management processes in alignment with regulatory standards.
Key Responsibilities:- Ensure compliance with regulatory standards (i.e., FDA, ICH GCP) and company SOPs throughout data management activities.
- Assist in the preparation of clinical data for regulatory submissions and audits.
- Provide data-related support during clinical trial activities and in interactions with regulatory agencies.
- Maintain detailed documentation of data management activities, including quality control measures and processes.
- Collaborate closely with clinical research teams, biostatisticians, and other stakeholders to support submission preparations and project goals.
- Bachelor's degree in Life Sciences, Data Management, Biostatistics, or relevant field.
- At least 7 years of experience in Data Management, with a focus on submission preparation.
- Proven experience in clinical data management, preferably within a pharmaceutical, biotechnology, or clinical research environment.
- Must have audit preparation experience and legacy studies experience.
- Strong knowledge of regulatory requirements and industry standards for clinical data management.
- A strong analytical and data-driven mindset.
- Excellent attention to detail and organizational skills.
- Strong communication and interpersonal skills, with the ability to work effectively in a team-oriented environment.
As a valued member of our team, you will have the opportunity to work on challenging projects, collaborate with experienced professionals, and contribute to the success of our clients. If you are passionate about clinical data management and have a proven track record in the field, we encourage you to apply today.
At Digital Prospectors, we are committed to fostering a diverse, equitable, and inclusive work environment. We believe that our differences are our strengths and strive to create a workplace where everyone feels valued and respected.
Apply now to take the first step towards a rewarding career with Digital Prospectors.
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