- Job Role: Clinical Data Manager
- Salary: Not Disclosed
- Location: Remote
- Company: ICON
- Qualifications: Bachelor’s degree
ABOUT ICON
ICON Canada is a leading clinical research organization (CRO) that provides outsourced offerings to the pharmaceutical, biotechnology, and clinical device industries. As part of ICON percent, an international issuer of outsourced development and commercialization offerings, ICON Canada gives a huge variety of solutions to guide medical trials across various therapeutic regions. The employer focuses on clinical trial control, data control, biostatistics, regulatory affairs, and pharmacovigilance.
ICON Canada is devoted to ensuring the achievement of clinical trials by turning in top-notch, well-timed, and value-powerful services. With a robust consciousness of innovation and affected person-centered care, ICON Canada facilitates customers to navigate the complexities of scientific improvement, accelerating the delivery of life-converting treatments to the marketplace. The company’s large experience, strong structures, and expert team make it a dependable partnerr in the international medical studies landscape.
Job Description:
A Clinical Data Manager (CDM) is liable for overseeing the gathering, control, and evaluation of medical trial statistics. They ensure the accuracy, integrity, and compliance of information with regulatory requirements. The position includes designing data control plans, developing databases, and acting in high-quality management checks. CDMs collaborate with medical groups, statisticians, and regulatory bodies to preserve facts consistency and record progress. They also manipulate statistics queries, solve discrepancies, and contribute to regulatory submissions, ensuring that trials are carried out correctly and statistics are reliable for choice-making.
Qualifications and Skills of a Clinical Data Manager:
Educational Qualifications:
- Bachelor’s Degree in Life Sciences, Biology, Nursing, Pharmacy, or associated fields is normally required. Advanced degrees (Master’s or Ph.D.) can be favored, in particular in scientific studies or records control.
- Certification in Clinical Data Management (e.g., CCDM – Certified Clinical Data Manager) from identified bodies like the Society for Clinical Data Management (SCDM) can enhance career prospects.
Key Skills:
- Clinical Research Knowledge: A Clinical Data Manager must have a solid knowledge of clinical trials, inclusive of stages, protocols, regulatory necessities (FDA, EMA, ICH-GCP), and Good Clinical Practice (GCP) tips. Familiarity with scientific trial design and facts glide is crucial.
- Data Management Expertise: Proficiency in coping with scientific facts, which includes creating, cleansing, and validating datasets, is critical. Knowledge of records control systems (e.g., Medidata Rave, Oracle Clinical, OpenClinica) and database management tools is a key ability.
- Analytical and Problem-Solving Skills: Strong analytical talents are important to perceive tendencies, discrepancies, or errors in statistics. Clinical Data Managers must possess hassle-solving capabilities to solve records problems and ensure the accuracy and completeness of datasets.
- Attention to Detail: Given the importance of accuracy in medical trials, meticulous attention to detail is important. Data ought to be very well reviewed to keep integrity, or even small mistakes can cause important outcomes in regulatory submissions.
- Project Management Skills: Clinical Data Managers often oversee multiple tasks and timelines. Strong organizational and undertaking management capabilities, which include the ability to manipulate sources, meet cut-off dates, and deal with competing priorities, are important.
- Communication Skills: Excellent written and verbal communication competencies are important for drafting information control plans, writing reports, and collaborating with clinical teams, statisticians, and regulatory authorities. Clear communication guarantees that everyone is aligned for the duration of the examination.
- Technical Proficiency: Correct information on statistical software programs(e.g., SAS, R) and familiarity with Electronic Data Capture (EDC) systems and scientific trial management structures (CTMS)are vital. Knowledge of information requirements like CDISC (Clinical Data Interchange Standards Consortium) is regularly required.
- Regulatory KnowledgeRobustst information on regulatory requirements for medical trials, inclusive of 21 CFR Part 11 (digital records), records privacy laws (GDPR, HIPAA), and submission tips for regulatory bodies is vital.
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