Lead Clinical Data Manager-Remote

At ClinChoice, the Lead Clinical Data Manager is responsible for overseeing all aspects of clinical data management for multiple studies. This includes developing and maintaining Data Management Plans (DMP), leading data cleaning efforts, managing the database design and validation, and ensuring compliance with regulatory guidelines like CDISC and GCP. The role also involves training junior team members and proactively participating in process improvement initiatives.

To be considered for the Lead Clinical Data Manager position at ClinChoice, candidates should hold at least a Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Computer Science, or a related field. Additionally, a minimum of 5 years of experience in clinical data management is required, with at least 2 years in a leadership role. Strong knowledge of clinical trial processes and hands-on experience with EDC systems such as Medidata Rave is essential.

Key skills for a Lead Clinical Data Manager at ClinChoice include excellent communication and problem-solving abilities, leadership skills, and strong organizational capabilities. A thorough understanding of clinical trial processes, regulatory requirements, and experience in oncology, immunology, or rare diseases would also be advantageous. The ability to work independently while building trust with clients is critical for success in this role.

ClinChoice is committed to the professional growth of its employees, providing continuous training and development opportunities. For the Lead Clinical Data Manager, this includes mentorship programs, access to industry seminars, and resources to enhance their skills and knowledge in clinical data management. This supportive culture allows individuals to thrive and stay at the forefront of industry advancements.

When applying for the Lead Clinical Data Manager position at ClinChoice, candidates can expect an acknowledgment of their application once submitted. If their qualifications match the requirements, they will be invited for a phone interview as the first step in the hiring process. ClinChoice values transparency and efficiency in its hiring, but due to the volume of applications, not all candidates may receive individual feedback.

When answering this question, discuss specific projects where you've led data management activities. Highlight your role in developing Data Management Plans, overseeing data cleaning processes, and ensuring compliance with regulatory standards. Use concrete examples to showcase your problem-solving skills and your ability to collaborate with cross-functional teams.

In your response, emphasize the importance of meticulous data cleaning, query resolution, and data validation at various stages of the trial. Mention your methods for checking compliance with guidelines like GCP and ICH, and how you involve your team in ensuring data quality, which is critical to successful outcomes.

Detail any experiences you have with EDC systems such as Medidata Rave, Oracle InForm, or Veeva Vault. Share how you've utilized these platforms in the data management process, including database design, validation, and user acceptance testing, to illustrate your Technical expertise.

Describe a specific challenge you faced in a previous position and the strategies you used to overcome it. Emphasize your problem-solving skills and ability to remain composed under pressure, as well as your ability to rally your team and find collaborative solutions.

Outline your leadership approach, whether it's democratic, transformational, or servant leadership. Provide examples of how you empower team members through mentoring, encourage open communication, and support continuous professional development to foster a positive work environment.

Stay updated on current trends like the integration of artificial intelligence in data management, the shift towards decentralized trials, and increasing focus on patient-centric data collection. Mention how these trends impact clinical studies and the importance of adapting to stay relevant in the field.

Discuss the specific steps you take to ensure compliance, including developing and reviewing Data Management Plans and training your team in compliance standards. Address how you keep up to date with any changes in regulations and disseminate that information within your team.

While the Lead Clinical Data Manager may not be directly responsible for statistical analysis, connect your experiences working alongside statisticians and how you facilitate collecting the necessary data for insightful analysis. Highlight collaboration with biostatistics to ensure data supports statistical endpoints.

Share your approach to client communication, including regular updates, transparency during challenges, and adapting your communication style to meet the needs of different clients. Discuss how you establish trust and build lasting relationships through effective collaboration.

Emphasize the importance of prioritization and setting boundaries to maintain your well-being in a fast-paced environment. Discuss any techniques you use for time management, and how fostering a positive and productive workplace contributes to achieving a healthy work-life balance.