Proclinical is seeking a remote Manager, Clinical Data Management for an innovative healthcare organization.
As part of a dynamic, multi-disciplinary team, the Manager will be responsible for planning, leading, and executing all Data Management tasks required for phase 1-4 studies.
The successful candidate will possess broad knowledge of the drug development process, as well as a strong understanding of data management principles, enabling them to perform most tasks with minimal guidance.
Must be eligible to work in the US.
Job Responsibilities:
- Lead Data Management Activities: Independently manage data management activities for clinical studies or related study series, demonstrating proficiency and autonomy in decision-making.
- Protocol and CRF Review: Provide valuable input and review for various study documents, including protocol, Case Report Form (CRF), off-site methodology, eCRF specification, Statistical Analysis Plan (SAP), Tables/Listings/Figures, and Clinical Trial Reports (CTRs).
- End-to-End Data Management: Take charge of all aspects of data management activities, starting from study startup through study close.
- Data Management Plan and Database: Oversee the development, review, and approval of essential data management documents, such as EDC/eCRF (following CDASH principles/standards), Data Validation Plan, Data Management Plan, User Acceptance Testing (UAT), etc. Ensure data review, query management, audits, and database lock processes are efficiently executed, resulting in a clean, GCP compliant, and analysis-ready final database.
- Coding and Vendor Management: Manage the approval process for adverse events coding, concomitant medication coding, and medical history coding (if applicable) and ensure SAE reconciliation. Also, handle data delivery specifications for external data, such as LAB, ECG, blinded read, etc. Develop requests for proposals (RFPs), establish vendor timelines, and effectively manage vendors' performance and progress against specifications.
- Budget Management: Take charge of budget management to minimize out-of-scope work and ensure cost-effectiveness.
- Communication and Documentation: Maintain effective communication with both internal teams and CROs (Contract Research Organizations). Ensure accurate and organized filing of essential documentation, adhering to standard operating procedures (SOPs) and contributing to their development.
- Continuous Improvement: Contribute to process improvements, support the evaluation of alternate vendors, and actively participate in enhancing SOPs and standards.
- Duties and responsibilities and is not exhaustive. Duties may evolve with changing business demands, and additional responsibilities may be assigned as needed.
Skills and Requirements:
- Bachelor's degree in a scientific/healthcare field (Master's Degree preferred).
- Minimum five years of Data Management experience in the pharmaceutical/biotechnology industry or an FDA-regulated environment, including study lead experience.
- Comprehensive Understanding: Demonstrated understanding of the scope and focus of Phase 1-4 clinical studies, with proven abilities in Data Management tasks and interactions with vendors. Previous experience with imaging agents is desirable.
- Regulatory Knowledge: Strong familiarity with regulatory guidelines and industry standards, including ICH/FDA guidance, CDISC CDASH, SDTM standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc., and their practical application in Data Management.
- Project Management and Multitasking: Excellent project management skills and the ability to multitask effectively, maintaining attention to detail while collaborating within a multi-disciplinary team and external partners and vendors.
- Communication Skills: Exceptional written and verbal communication skills, with professional proficiency in the English language.
- Results-Oriented Team Player: Proven ability to think clearly, prioritize customer needs, seek input from various disciplines, and provide focused solutions. Demonstrated adaptability to change, excellent organizational skills, and a quality-focused and accountable work approach.
- Knowledge, skills, and abilities in clinical SAS programming, mapping and creation of legacy, SDTM, ADaM datasets, SDTM, ADaM Reviewers Guide (SDRG), define.xml, and pinnacle validation; experience with regulatory submissions, along with strong data management expertise and the ability to take on tasks with minimal guidance, will be considered.
If you are having difficulty in applying or if you have any questions, please contact Paula Bonilla at +(1) 305-929-0913 or p.bonilla@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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