About Company
Pioneering advancements in healthcare through meticulous data management, Hiring.zycto offers a dynamic and intellectually stimulating environment for data professionals. We are a forward-thinking organization dedicated to optimizing clinical trials and ensuring data integrity, driving impactful research outcomes. For a Clinical Data Manager, this means working with cutting-edge technologies, collaborating with interdisciplinary teams, and directly contributing to projects that transform patient care globally. Join us to leverage your expertise in a role that values precision, innovation, and unwavering commitment to ethical data practices, all while enjoying the flexibility of a remote work model within a supportive culture. Your analytical skills will be pivotal in our mission.
Job Description
Hiring.zycto is seeking a highly skilled and motivated Remote Clinical Data Manager to join our growing team. In this pivotal role, you will be instrumental in ensuring the integrity, quality, and accuracy of clinical trial data, ultimately contributing to the successful development of life-changing therapies. As a Clinical Data Manager, you will oversee all data management activities from study startup through database lock, collaborating closely with clinical operations, biostatistics, and programming teams. This is a fantastic opportunity for an experienced professional to leverage their expertise in a remote capacity, making a significant impact on global health initiatives. We are looking for someone with an eagle eye for detail, a deep understanding of regulatory guidelines (e.g., ICH-GCP), and a passion for optimizing data processes. You will be responsible for developing and maintaining data management plans, designing CRFs, conducting data reviews, and ensuring compliance with all relevant standards and procedures. If you thrive in a fast-paced environment and are committed to upholding the highest standards of data quality, we encourage you to apply and become a key contributor to our mission of advancing medical science.
Key Responsibilities
- Develop, implement, and maintain Data Management Plans (DMPs) for assigned clinical studies.
- Design, test, and validate Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems.
- Perform comprehensive data review, query generation, and resolution to ensure the integrity, quality, and accuracy of clinical trial data.
- Oversee all database lock procedures, ensuring timely completion of data management activities in line with study timelines.
- Collaborate effectively with cross-functional study teams, including clinical operations, biostatisticians, and programmers, to facilitate seamless data flow and resolve discrepancies.
- Ensure strict compliance with Good Clinical Practice (GCP), regulatory requirements (e.g., FDA, Health Canada), and internal Standard Operating Procedures (SOPs).
- Participate in the development and review of clinical study protocols, statistical analysis plans, and other essential study documents.
- Provide expert input on data standards, contribute to process improvement initiatives, and mentor junior team members as needed.
Required Skills
- Minimum 4 years of progressive experience in Clinical Data Management within pharmaceutical, biotechnology, or Contract Research Organization (CRO) environments.
- Proven proficiency with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle InForm, Veeva Vault EDC).
- Strong understanding of ICH-GCP guidelines, 21 CFR Part 11, and other relevant regulatory requirements for clinical trials.
- Exceptional analytical, problem-solving, and organizational skills with meticulous attention to detail.
- Advanced knowledge of medical terminology, clinical trial phases, and data management processes.
- Demonstrated ability to manage multiple complex projects simultaneously, prioritize tasks effectively, and consistently meet deadlines.
- Excellent communication and interpersonal skills, both written and verbal, for effective collaboration with diverse teams.
Preferred Qualifications
- Bachelor's or Master's degree in a life science, health informatics, computer science, or a related scientific field.
- Experience with statistical programming languages (e.g., SAS, R, Python) for data validation or reporting purposes.
- Familiarity with CDISC standards (SDTM, ADaM, CDASH) and their application in clinical data management.
- Prior successful experience working in a fully remote or hybrid work setting.
- Certification in Clinical Data Management (e.g., CCDM) is a plus.
Perks & Benefits
- Competitive annual salary and performance-based bonus structure.
- Comprehensive health, dental, and vision insurance plans.
- Generous paid time off, including vacation, sick leave, and company holidays.
- Flexible and supportive remote work environment.
- Robust opportunities for professional development, continuous learning, and career advancement.
- Access to cutting-edge technologies and participation in innovative, impactful projects.
- Employee assistance program and various wellness initiatives.
- A collaborative, inclusive, and highly engaged team culture.
How to Apply
To seize this exciting opportunity, please click on the application link below and submit your resume along with a compelling cover letter detailing your relevant experience and why you are the ideal candidate for this pivotal remote role. We eagerly look forward to reviewing your application!
