This job opportunity is no longer available.
This page has been archived for your
reference. You can try to continue to this position on the employer's website
or try a new search. Inquiries related
to this position should be directed to the employer.
Description
About Celgene
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 60 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology and hematology. If youd like to join a company where you can make a difference, please consider the Celgene family.
Prerequisites
Completed BS or MS degree in a scientific discipline required.
Minimum of 5-7 years' experience within pharmaceutical industry in clinical research with demonstrated ability to efficiently oversee and/or manage multiple clinical studies required.
Institution/protocol experience also required.
Summary
The Cooperative Clinical Manager (CCM) represents the company to cooperative groups and develops operational models for individual cooperative groups in alignment with Celgenes strategy. He or she will be responsible for coordination and management of all activities related to a specific leading cooperative group, and functions as the primary communicator with the coops investigator sites.
Responsibilities will include, but are not limited to the following:
1. Collaboration and partnership cross functionally with coops Principle Investigators (PIs) and study coordinators
Coordinate studies between different cooperative groups and institutions
Coordinate studies between different investigators and the same cooperative group
2. Implementation and protocol development
Review and comment on synopsis, protocol, Informed Consent and CRFs with study PI and
study coordinator
Facilitate and Monitor timelines for protocols
Review essential regulatory documents as needed
3. Negotiate and develop protocol specific budgets
4. Facilitate contracts and monitor timelines
5. Collaborate with study manager about protocol initiation and or site start up
Represent Celgene at site initiation and follow up visits as needed
6. Enrollment and maintenance of subjects
Ensure accruals are tracked and recorded appropriately
Compile accruals status
Identify enrollment and retention issues and notify Director of Cooperative Group for
implementation of accrual strategic plan
Verify milestones for site payment
7. Conduct site audits for validation of the data points relative to study outcomes and sites performance
8. Evaluate clinical risks and develop effective solutions for conflict avoidance and resolution
9. Manage details and logistics to ensure for accurate and timely publications/manuscripts-
Ensure expeditious accrual to trial
Ensure pertinent and accurate data at time of completion of study
Facilitate answers to data queries allowing for timely statistical analysis
Facilitate communications between data center, statistical center and Principle Investigator
Provide timeline to the Principle Investigator regarding publication
10. Understands hematologic malignancies and is involved in the developmental aspects of disease therapeutics.
11. Execution of clinical drug dispercement- Partner w/ clinical specialists
12. Utilize National Cancer Institute (NCI) data system for safety/efficacy
Interface externally with NCIs drug lead and NCIs IT department; internally with Celgenes
Drug Safety and Celgenes IT department to answer queries from FDA and EMEA by
accessing NCIs data bases with patients participating on Celgene drugs in the past 10
years.
Generate publications to guide community physicians on how to manage Celgene
compounds in various diseases
Generate hypothesis for the academic community for well designed clinical trials.
13. Work in conjunction with Medical Services to develop appropriate/pertinent resource material to be distributed upon request to physicians in targeted disease states.
Specific Requirements:
Completed BS or MS degree in a scientific discipline required.
Minimum of 5-7 years' experience within pharmaceutical industry in clinical research with
demonstrated ability to efficiently oversee and/or manage multiple clinical studies required.
Institution/protocol experience also required.
Proven ability to establish relationships with top thought leaders across multiple specialties.
Ability to understand the clinical trial process and assist investigators in the development of
protocols.
Ability to negotiate budgets.
Ability to monitor progress and hold outside personnel to timelines.
Ability to work with individuals within several different functioning units.
Equal Employment Opportunity
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.
Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employees temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the at-will employment relationship between the employee and Celgene.
Details:
Job Id:
18651576
Posted / Updated:
3/24/2010 3:51:45 AM
Map
Careers & Community for Talented People with Disabilities