Other Locations:US- NJ- Summit East
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.
Summary/Scope: This position serves a key role within the assigned Therapeutic Area Team. The CRS works closely with the study team to support the activities associated with a clinical study. This position collaborates with clinical team members as well as with functions outside of clinical to provide deliverables. The CRS is responsible for achievement of personal goals which support study team and project team goals.
Responsibilities will include, but are not limited to, the following:
- Support assigned study level activities with a minimal level of supervision (may lead or co-lead a study or study activities)
- Thorough understanding of assigned protocol and protocol requirements
- Successfully plans execution of deliverables
- Support all study start up/conduct/close-out activities as applicable
- Preparation, storage, maintenance of clinical documents (TMF)
- Coordination of protocols & amendments; may author with guidance
- Review and validation of clinical study reports (CSRs); demonstrate basic understanding the connection between the data and the CSR
- Conduct literature review as needed
- Provide study related information to support Regulatory Documents (e.g., IB, Briefing Books)
- Review Informed Consent Forms (ICF); may author a global or regional ICF template
- Preparation of site and CRA training materials; may present information
- Country/site selection activities as requested
- Collaboration with Clinical Operations for budget preparation, CRO scope, etc. (i.e., review and provide feedback on activities/instructions/deliverables related to study data, IVRS, central labs, patient reported outcomes)
- Support study committee (e.g., DMC) activities (e.g., charters, meetings, presentations)
- Support Investigator Meeting and SIV planning/facilitation, including slide preparation
- Review clinical data for specific trends, mine data to support responses to HA or EC questions as requested
- Clinical review of study data (conduct clinical data review, communicate as necessary to resolve data queries, draft/update/review data review plans, support Clinical Research Physician in data review (generation of reports, action plans, trend identification), etc)
- Collaborate with study team members including: Clinical Operations, Data Management, Statistics, Drug Safety, IMSC, Regulatory Affairs, Translational Medicine and Project Management (set-up and/or lead meetings as appropriate)
- Regularly attend and actively participate in study team and other clinical meetings.
- Seek out and enact best practices with minimal instruction; contribute to process improvement.
- Actively seek and receive coaching/mentoring; may provide guidance to junior members of team.
- Contribute to preparations for external/stakeholder meetings (e.g., IMs, Governance)
- May present data/information to external investigators or study staff (e.g., SIV presentations)
- Provide regular and timely updates to manager
- Identify & escalate current/future issues; may propose solutions
- Set own priorities with moderate guidance from manager.
- May support program level activities as requested.
- At least 4 years of experience in CR&D roles/responsibilities or equivalent
- Knowledge of GCP/ICH, overall drug development process from discovery to registration, study design, statistics, clinical operations
- Excellent verbal, written, communication and interpersonal skills
- Demonstrates initiative
- Knowledge and skills to support program specific data review and trend identification
- Knowledge of Medical Terminology and basic medical writing skills
- Knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA & safety profile)
- Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.
- Proficient critical thinking & problem solving skills
- Understanding of functional and cross-functional relationships
- Commitment to Quality
- Adaptable / Flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
- Strong planning/project management skills (ability to develop short range plans that are realistic and effective in meeting goals)
- Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools
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.