Manager, Trials Safety Job

Organization
Celgene
Job Location
Berkeley Heights, NJ
Job Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Key Activities:

Study level support
- Provide safety support and surveillance for clinical studies, as assigned
- Assist study teams in implementing, executing and concluding trials
- Review study-specific protocol, ICF, CRF
- Review study-specific CRO-related documents (SOW, monitoring plans, TORO, contracts, etc)
- Provide safety training to site and study personnel
- Train case processing staff in new protocols
- Complete additional study start up activities
- Review new clinical cases for internal discrepancies and liaise with case management on corrections
- Participate in SAE reconciliation
- SMT / DMC preparation, presentation, documentation, and logistical support
- Contribute to & participate in product review meetings
- Review study-specific Statistical Analysis Plan (SAP) and statistical outputs (e.g. tables, listings & graphs [TLGs])
- Provide safety strategy and guidance to medical writers for Clinical Study Report (CSR) & perform review of CSR
- Respond to Ad Hoc Investigator / IRB / EC Queries
Logistics/Other
- May train, mentor and coach trial safety associates
- Develop SOPs & WPs relevant to function, as applicable
- Assist in creating & maintaining processes & content templates for safety documents
- To oversee quality, standardization & logistics of safety document preparation
- Other activities as dictated by business needs
Output/Deliverables:

Study level support
- Study-specific SAE reporting plan, study-specific SAE report form/guidance document, pregnancy report forms/guidance document, risk/benefit assessment for EU CTAs
- Safety reporting training slides
- Study-specific work aid, training slides as applicable
- Line listings and frequency reports from the safety database
- SMT/DMC charters, presentations, meeting schedules / minutes
- Study-specific product updates
- SAP, TLGs
- Responses to ad hoc site queries
Logistics/Other
- Orientation plan, training materials
- SOPs, WPs
- Templates for safety documents, as applicable
- QC process/findings documentation, as applicable
Knowledge:
- Expert knowledge of the global safety environment, international regulations and guidance documents
- Clinical knowledge of therapeutic area patient population and drugs
- Appreciation of the product development life cycle and clinical trials
- Working knowledge of safety data capture in clinical trial settings and familiarity with clinical database systems
- Proficient in computer applications such as ARISg, Business Objects/Business Intelligence, Spot Fire, J-review
- Proficient in MedDRA coding and SMQ use
Competencies:
- Communication (written and oral)
- Critical thinking
- Organization and planning
- Team work
- Analytical skills
- Attention to detail
- Able to exercise judgment on matters that require further input from others vs. not
- Able to work in a team, matrix environment and as an independent contributor
- Multi-tasking of multiple studies across compounds

Qualifications
Prerequisites:
- Pharmacy/Nursing (eg, BS, MS, PharmD) or other degree with the equivalent combination of relevant education and professional experience

- At least 3 years relevant pharmaceutical/CRO industry experience

- Experience in clinical R&D, clinical safety, and/or safety case management

- Experience in aggregate safety data analysis, interpretation and writing

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

*LI-RM1

Req ID: 15000687
Primary Location: United States-New Jersey-Berkeley Heights
Job: Quality
Organization: Celgene Corporation
Schedule: Regular
Shift: Standard
Employee Status: Manager
Job Type: Full-time
Job Level: Day Job
Travel: Yes, 5 % of the Time
Job Posting: 2015-03-25 00:00:00.0

Requirements: 

Business Intelligence, Clinical Research, Data, Data Analyst, Database, ERP, Healthcare, Management, Manager, Medical, Medical Research, Pharmaceutical, Pharmacy, Product Development, R&D, Research, SAP, Safety, Science, Service, Statistics, Technology, Travel Nurse 

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