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Senior Clinical Data Manager(MA) |
| Eligibility : |
BS/BA in a scientific discipline |
| Location : |
MA/Other |
| Designation : |
Senior Clinical Data Manager(MA) |
| Details :: |
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Makro Technologies |
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Job Description:
In this role, you will handle detailed Data Management issues for all phases of clinical trials (Phase 1- 4) including oversight of CRO data management activities. Additionally, you will participate in study planning and initiation data activities (e.g., CRF design, database design, annotated CRF, and edit check/Data Management Plan development in conjunction with the clinical study team ensuring application of company data standards. You will also ensure the accuracy, completeness, and consistency of clinical databases, carry out safety and microbiology data loading/transfer procedures, prepare materials for NDA vendors, actively participate in the NDA and e-submission process, prepare ad hoc data listings and review analysis tables, listings, and figures for consistency and accuracy. Moreover, you will be expected to work closely with lead study and project managers to develop timelines and review budgets and contracts to ensure departmental and corporate clinical trial data management objectives are met, as well as develop and update SOPs, departmental guidelines, data standards and other activities to support DM and biostatistics as needed.
Requirements:
Top candidates for this position will have a minimum of a BS/BA in a scientific discipline or equivalent, a minimum of 5 years experience as a Data Manager (lead experience required) in a CRO or Pharmaceutical/Biologics/Medical Device company, and experience as a lead CDM managing studies from preparation through close-out (including data management activities related to study conduct, study completion, and archiving of study materials). Demonstrated experience with a data management system (e.g., Clintrial, Oracle Clinical or an EDC system), ability to work interdependently with minimal supervision, and excellent written and oral communication skills are required. Familiarity with coding of medications, medical conditions, and AEs/SAEs using MedDRA and WHODRUG dictionaries is necessary; Proficiency in basic SAS and/or JMP (preferred) or a demonstrated ability to learn basic programming skills is fundamental.
About Verna Scientific:
Verna is a multidisciplinary Life Sciences firm, Verna specialize in Consulting and Staffing services for Fortune 1000 as well as start-up companies in Biotech, Pharmaceutical and Healthcare industries with major focus on clinical research and data management. Verna is growing rapidly and we are always looking for individuals with outstanding capabilities in clinical arena. We offer careers in both technology and research disciplines. Verna's expertise has earned us an esteemed reputation within the industry and with our clients such as Schering-Plough, Astra Zeneca, Purdue, Abbott Labs, Merck, Wyeth, Allergan and Amgen.
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About Verna Scientific:
Verna is a multidisciplinary Life Sciences firm, Verna specialize in Consulting and Staffing services for Fortune 1000 as well as start-up companies in Biotech, Pharmaceutical
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| Salary : |
Not specified |
| Company URL : |
http://www.vernascientific.com |
| Last Date : |
2008-03-13 |
| Address: |
Srilaxmi |
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| Keywords: jobs, medical jobs, medical career, medical device jobs, medical device sales career |
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