Are you passionate about ensuring the accuracy, security, and integrity of clinical trial data that could lead to breakthrough therapies and improved patient outcomes? Do you have the expertise to manage the entire lifecycle of clinical data, from collection and validation to analysis and reporting? If you're ready to play a crucial role in the success of clinical trials, our client has the perfect opportunity for you. We’re seeking a Clinical Data Manager (aka The Guardian of Data Integrity) to oversee the management of clinical data, ensuring that it meets the highest standards of quality, compliance, and reliability.
As a Clinical Data Manager at our client, you will work closely with clinical research teams, data analysts, and regulatory affairs professionals to ensure that all clinical data is collected, validated, and reported in accordance with regulatory requirements. Your role will be central to the success of clinical trials, ensuring that data supports the development of safe and effective therapies.
Key Responsibilities:
1. Oversee Data Collection and Validation in Clinical Trials:
o Manage the entire clinical data lifecycle, from designing data collection processes to overseeing database development. You’ll ensure that data is collected efficiently and that quality control measures are in place to validate data accuracy.
2. Develop and Maintain Clinical Databases:
o Design, implement, and maintain clinical trial databases using platforms such as Oracle Clinical, Medidata Rave, or REDCap. You’ll ensure that databases are user-friendly, secure, and compliant with regulatory standards like FDA and ICH guidelines.
3. Collaborate with Cross-Functional Teams:
o Work closely with clinical researchers, biostatisticians, and regulatory affairs teams to ensure alignment on data collection needs and compliance with study protocols. You’ll coordinate efforts to ensure data quality and completeness throughout the clinical trial.
4. Ensure Compliance with Regulatory Standards:
o Ensure that all clinical data management activities are compliant with regulatory requirements, including FDA, EMA, and ICH-GCP guidelines. You’ll establish procedures that ensure data integrity, security, and traceability throughout the clinical trial process.
5. Perform Data Cleaning and Validation Processes:
o Oversee data cleaning, query management, and validation activities to ensure data quality. You’ll develop and implement data validation rules, monitor discrepancies, and resolve data queries in collaboration with clinical teams.
6. Create Data Management Plans (DMPs):
o Develop and maintain comprehensive Data Management Plans (DMPs) for each clinical trial, detailing data collection procedures, database specifications, validation protocols, and data security measures.
7. Support Data Analysis and Reporting:
o Work closely with data analysts and biostatisticians to provide clean, validated data for analysis. You’ll support the generation of clinical study reports (CSRs), interim analyses, and regulatory submissions.
Requirements
Required Skills:
* Clinical Data Management Expertise: Extensive experience in managing clinical trial data, from data collection to validation and reporting. You understand the complexities of clinical trials and the importance of ensuring data quality and regulatory compliance.
* Database Management and Development: Proficiency in building and managing clinical trial databases using platforms like Medidata Rave, Oracle Clinical, or REDCap. You’re experienced in designing user-friendly databases that support efficient data collection and validation.
* Regulatory Knowledge: Deep understanding of regulatory standards, including FDA, EMA, and ICH-GCP guidelines, and how they apply to clinical data management. You know how to ensure that data handling processes meet these requirements.
* Data Validation and Quality Control: Expertise in performing data validation, cleaning, and query resolution. You can develop data validation protocols and monitor data integrity throughout the clinical trial.
* Collaboration and Communication: Strong collaboration skills with the ability to work with cross-functional teams, including clinical researchers, regulatory professionals, and data analysts. You’re skilled in communicating data-related issues and solutions clearly and effectively.
Educational Requirements:
* Bachelor’s or Master’s degree in Life Sciences, Data Science, Clinical Research, or a related field. Equivalent experience in clinical data management is highly valued.
* Certifications in Clinical Data Management (CDM) or GCP compliance are a plus.
Experience Requirements:
* 3+ years of experience in clinical data management, with hands-on experience managing data for clinical trials, including Phase I-IV studies.
* Experience working with clinical trial databases such as Medidata Rave, Oracle Clinical, or similar platforms.
* Experience in regulatory environments and working with FDA or EMA submissions is highly desirable.
Benefits
* Health and Wellness: Comprehensive medical, dental, and vision insurance plans with low co-pays and premiums.
* Paid Time Off: Competitive vacation, sick leave, and 20 paid holidays per year.
* Work-Life Balance: Flexible work schedules and telecommuting options.
* Professional Development: Opportunities for training, certification reimbursement, and career advancement programs.
* Wellness Programs: Access to wellness programs, including gym memberships, health screenings, and mental health resources.
* Life and Disability Insurance: Life insurance and short-term/long-term disability coverage.
* Employee Assistance Program (EAP): Confidential counseling and support services for personal and professional challenges.
* Tuition Reimbursement: Financial assistance for continuing education and professional development.
* Community Engagement: Opportunities to participate in community service and volunteer activities.
* Recognition Programs: Employee recognition programs to celebrate achievements and milestones.