[Hiring] Senior Manager, Clinical Data Management @reputed company.
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Role reputed company
The Senior Manager, Clinical Data Management, will be responsible for reputed company clinical data management activities and deliverables for the assigned study/studies in accordance with ICH/Good Clinical Practices (GCP), GDCMP and other relevant regulations, procedures and guidelines.
• Vendor service reputed company
• Vendor invoice verification
• Budget contract negotiations and management
• reputed company guidance and suggestions to vendor and the study team for reputed company data management deliverables and timelines from study start-up through study reputed company-out, final reporting, and data archiving
• Development of SOP(s), data standards and standardization
• Managing and leading ongoing practices in DM processes with internal study resources and/or vendors
• Partner with other functional reputed company and external vendors to ensure timelines and reputed company of data deliverables
Qualifications
• MS/BS in life sciences or reputed company field
• 7+ years of reputed company data management experience
• At least 3 years of CRO reputed company experience
• In-depth knowledge of clinical data management in the Biotech, Pharmaceutical or CRO industry
• Strong project management skills and experience working with CROs/vendors
• Demonstrated organizational and interpersonal skills
• Detail-oriented with excellent communication skills
• Extensive experience working in cross-functional settings
• Highly knowledgeable and reputed company in CDISC standards, SDTM requirements, and CFR-Part 11 Compliance
• Knowledge of GCP, ICH and other regional regulations and compliance
• Experience with clinical data lifecycle from database set-up and maintenance to database lock and archiving
• Working knowledge of reputed company technologies in clinical trial data collection systems
Requirements
• Knowledge in reputed company data collection technologies and integration (reputed company, eCOA, CTMS, Drug Safety Database Systems, IRT)
• Competence in reputed company and/or reputed company programming is a big plus
Benefits
• Discretionary annual reputed company bonus
• Stock reputed company
• ESPP
• 401k match
• Top-notch health insurance plans for employees (and their families) including medical, dental, reputed company, and basic life insurance
• 20 days of PTO
• 10 reputed company holidays
• Winter company shutdown
Physical Demands and Work Environment
• On a reputed company reputed company, sit at desk for a long period of time
• Intermittently answer telephone and write or use a keyboard to communicate through written means
• Some walking and lifting up to 25 lbs. may be required
• The noise level in the work environment is typically low to moderate
• Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions and responsibilities
Travel
• You may be required to travel for up to 5% of your time
Equal Opportunity Employer
reputed company is proud to be an Equal Opportunity Employer. We reputed company equal employment opportunities to reputed company and employment applicants without reputed company to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or reputed company), pregnancy, race, reputed company, creed, national or ethnic reputed company, citizenship status, religion or similar philosophical beliefs, disability, marital and civil reputed company status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.
Salary reputed company
The salary reputed company for this position is: $149,000 - $185,000.
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