Key Tasks & Responsibilities
- Perform quality control activities (i e,
- documentation review, testing) of Professional Service deliverables including eCRFs, Data Validation Specifications, Data Extracts, Data Integrations, Data Mapping, and Custom Reports
- Participate in the design and development of quality control procedures
- Manage documentation created during the QC process
- Collaborate with the project team to ensure the deliverables are completed on time with high quality
- Ensure compliance with eClinical Solutions / industry quality standards, regulations, guidelines and procedures
- Other duties as assigned
CANDIDATE'S PROFILE
Education & ExperienceBachelor's degree or equivalent work experience preferredExcellent knowledge of EnglishProfessional Skills
3+ years in Pharmaceutical / Biotechnology industry or equivalent preferredKnowledge of ICH / GCP guidelines, 21 CFR Part 11, clinical trial methodology, software development lifecycle activities and industry standards (CDASH, SDTM) preferredExperience performing quality control activities of clinical trial deliverables preferredExcellent verbal and written communication skillsDetail oriented, ability to multitask with strong prioritization, planning and organization skillsExcellent team playerTechnical Skills
Proficiency in Microsoft Office Applications, specifically MS Word and MS ExcelAccelerate your skills and career within a fast-growing company while impacting the future of healthcareWe have shared our story, now we look forward to learning yours!eClinical Solutions is a people first organizationOur inclusive culture values the contribution that diversity brings to our businessWe celebrate individual experiences that connect us and that inspire innovation in our communityOur team seeks out opportunities to learn, grow and continuously improveBring your authentic self, you are welcome here!We are proud to be an equal opportunity employer that values diversityOur management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business needSkills Required
Ms Excel, Ms Office Applications, Quality Control, Data Extraction, Data Integration, Data Mapping