Hi ,
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As discussed please go through the below position, if you are comfortable share the below required details along with your DL and Visa Copy ASAP.
Position/Role: Clinical Reporting Lead
Client: Allergan Pharmaceuticals
Duration: 1 year plus extension
Location: Irvine, CA
C2C Pay Rate: DOE
Interview Mode: 1st Round Phone, 2nd Round Face to Face. (Skype is not an option)
Under the direction of management, the Clinical Reporting Lead will lead the design, development, validation, rollout of reports/dashboards using business intelligence tools (e.g., Spotfire, J‐Review, Power BI) and programs (e.g., SQL, PL‐SQL, R, SAS) used in Clinical Research and Development studies. Additionally, the Clinical Reporting Lead will analyze Clinical Study design requirements against third party system specifications to support the implementation of electronic systems (e.g., electronic diaries) used in Clinical studies.
The Clinical Reporting Lead will also assist in the validation of electronic systems and programs as implemented internally or through external vendors according to current regulatory requirements.
The Clinical Reporting Lead will act in a project management role managing various study related projects and initiatives. The Clinical Reporting Lead must be innovative and forward thinking in support of next generation reporting needs (e.g. advanced and predictive data review).
The Clinical Reporting Lead must conduct activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all Allergan policies, and procedures. Allergan policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
Education and Experience:
BS/BA degree with 6 min. years’ experience, or MS degree with min. 4 years of experience in
Life Science, Computer Science, or related field required
Strong Project Management and Communication skills
Strong knowledge of databases, such as Oracle
Strong knowledge of Power BI
Knowledge of visualization tools, such as TIBCO Spotfire, etc.
Knowledge of clinical reporting tools (e.g. Cognos, J‐Review, SQL, PL‐SQL, SAS, etc.)
Knowledge of industry specific data standards e.g., CDASH, CDISC ODM/SDTM
Ability to work with diverse user groups, lead discussions on and creation of User
Requirements and Design documentation
Support creation and maintenance of standard report libraries
Liaise with other technical personnel in related functions, as needed
Knowledge:
Intermediate knowledge and understanding of Regulatory Guidelines for the use of computer systems in clinical studies
Intermediate knowledge of Clinical Data Management and Clinical Programming methodologies as well as current and emerging global industry standards
Working knowledge of global standards related to clinical study data management activities (CRF design, data standards, database design, coding and coding dictionaries, etc.)
Intermediate knowledge of Research & Development (R&D) and an understanding of regulatory guidelines/requirements related to R&D (e.g., ICH, GCP, safety reporting)
Note: While this job description is intended to be an accurate reflection of the job requirements, management reserves the right to modify, add or remove duties from a job and to assign other duties as necessary and at any time.
Full Name as per Passport | |
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Relocation (Y/N) | |
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LinkedIn Id | |
Date of Birth (MM/DD) | |
SSN last 4 Digits | |
Highest Education & Year of Passing | |
Visa Status (Attach Visa Copy) | |
Validity | |
Interview - Slots for next 2 days | |
W2 or C2C | |
Total Years of Experience | |
Skype ID | |
Currently on Project (Yes / No) | |
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Rate | |
Arun Reddy
IT Recruiter
(W) 312-985-0412
22260 Haggerty Rd, Suite # 285,Northville, MI 48167.
www.rsrit.com
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