Req #: 1903685
Location: Boudry, Neuchatel, Switzerland
Job Category: Medical
Work Location: Route de Perreux 1 2017
Organization: Clinical Research Scientist
Employee Status: Full-time
Job Type: Temporary
Here at Celgene, we are seeking an experienced and self-sufficient Clinical professional to play a pivotal role in the progress of our CAR T clinical work, and to join our team as Clinical Research Scientist.
As we seek to push the boundaries of medical innovation, we are seeking an individual who is knowledgeable / well-versed in verifying and reviewing clinical data - you will, therefore, have experience from either a Clinical Research Organisation (CRO) or a pharma/biotech setting,
As a Clinical Research Scientist, you will play a key role within the Lymphoma Team. Working closely with the study team, you will support the clinical study activities as well as collaborate with clinical team members - you will also liaise closely with non-Clinical team members as to provide deliverables.
Because of this, it is essential that you have experience from within Hematology or Oncology.
In this role, you will be empowered to achieve your personal goals which support study team and project team goals - this will be aided by your colleagues, a diverse and experienced set of individuals who form the Global team.
Please note: This is a 12-month temporary assignment, based out of our International HQ in Neuchatel, Switzerland.
(due to acute business needs, preference will be given to those candidates who are already located in Switzerland and available at short notice)
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.
IN MANAGER's WORDS, the top 3 requirements are:
1. Clinical/Medical background and experience as a Clinical Research Scientist
2. Must have at least two years of direct HEMATOLOGY/ONCOLOGY experience in a Clinical Research and Development capacity
3. Must be able to function independently
- 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.
- 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
COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.