资深数据团队负责人（南非，居家办公）
Senior Data Team Lead (South Africa, Home-Based)
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
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This position is a home-based role out of any location in South Africa.
Senior Data Team Lead
Roles & Responsibilities:
- Responsible for entire data management process from study set-up to study close-out; primary contact for clients and internal management on all data management issues; has high level knowledge of drug development as it pertains to data management.
- Strong understanding of GCP/ICH guidelines and FDA regulations, as applicable to data management.
- Actively participates in protocol review with clients, providing suggestions regarding ability to capture protocol information in database successfully.
- Creates training exercises; serves as mentor and trains new clinical data managers.
- Provides oversight and resolves all issues in data management study processing activities. including CRF tracking and data entry, integration of external electronic data (e.g. lab data) with clinical database, data validation and review, query processing and resolution, adverse event and medication coding, SAE reconciliation, database lock and database QC audits.
- Oversees and develops data management study documentation including Case Report Forms, CRF Completion Guidelines, Database Design via annotated CRFs, Validation specifications (edit checks), and Data Management Plan.
- Prepares any study tracking and metric reports for use by the study team.
- Oversees execution of user acceptance testing (UAT) of study-specific systems and applications.
- Interacts with cross-functional team members to ensure completion of all timelines and studies.
- Leads data management and/or organizational initiatives.
- Authors SOP updates and provides specifications for DM systems/tools and process improvements.
- May act as a high-level APP resource for cross-functional team, as requested.
- Actively participates/authors outside data transfer agreements and reconciliations.
- Understands and follows processes related to project management as appropriate for data management projects (e.g. updating PWA, close-out procedures, etc.).
- Displays a confident, positive attitude towards clients and projects.
- Willing to learn new skills and expand knowledge of drug development.
- Leads data management projects with little management oversight.
- Ability to work independently and resolve issues.
- Complete compliance to applicable IMS policies and procedures and ensures compliance of DM team.
Job Requirements:
- College graduate in scientific or healthcare field discipline or related field, or related experience, masters preferred.
- 8+ years’ experience in data management field with a minimum of 3 years’ experience leading projects.
- Expert knowledge of scientific principles and concepts.
- Intermediate SAS or other relevant programming skills, with extensive experience in relational databases.
- Extensive knowledge of paper CRF study systems, EDC, and hybrid CDM systems.
- Extensive knowledge of Clinical Operations SOPs and WPs.
- Excellent verbal and written communication skills, as well as, interpersonal and organizational skills.
- Proficiency with MS Office applications.
- Hands-on experience with clinical trial and pharmaceutical development preferred.
- Excellent problem-solving skills.
- Good organizational skills.
- Familiarity with current ISO 9001 and ISO 27001 standards preferred.
- Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
Should you not receive a response on your application within 14 days, please consider your application unsuccessful.Originally posted on Himalayas