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CLINICAL RESEARCH ASSOCIATE
From:
Company: Millennium Pharmaceuticals, Inc. (see all of this employer's jobs)
Department MLN, P.O. Box 321
, 02454
United States
Contact: www.millennium.com
Apply by eMail:15339634.185@jobfrenzy1.com
Apply by eMail:15339634.185@jobfrenzy1.com
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Job Reference ID:
DF15339634
Category:
General Management
Duration:
Full Time
City, ST:
Cambridge, Massachusetts
Country:
United States |
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Description:
Company Information:
Breakthrough Careers!
A career at Millennium: The Takeda Oncology Company comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality.
Position Summary:
Provides clinical operations management for assigned investigator initiated studies (IIS), including timelines, subsite management, and key project deliverables.
Duties and Responsibilities:
Leads operational component of IIS
Works with Medical Science Liaisons and principal investigator and his/her staff to drive development of approved LOI concepts through to study activation, enrollment and study closeout
Coordinates and drives completion of the protocol draft, final protocol and main site informed consent form, and, if applicable, investigator IND submission
Provides regular updates to IIS Program Manager and Global Medical Affairs Medical Director the overall clinical strategic operations plan for studies including timelines, key deliverables and key operational issues.
Coordinates and presents at operational site visits
Reviews and comments on proposed trial budgets
Drafts budget/payment terms for applicable contract appendices
Develops and manages study timelines
Reviews and submits clinical trial material orders
Submits and maintains IIS data and milestones in the IIS CTMS database
Qualifications:
Basic qualifications: BA/BS/RN/RPh (preferably in healthcare/science field) with 3+ years of progressive experience in clinical operations, preferably in late stage/IIS management
Preferred qualifications:
Thorough understanding of FDA, ICH, and GCP guidelines as well as a thorough understanding of cross-functional clinical processes including global medical affairs, pharmacovigilance, legal/contracts, and regulatory affairs
Ability to lead a cross-functional team in a matrix environment
Excellent interpersonal and negotiation skills
Strong verbal and written communications and presentation skills
Proven problem solving and decision making skills
Strong leadership, planning and project management skills
Ability and willingness to travel 10% of the time (domestic)
Requirements:
See Above
Education: Not Specified
Experience: 3-5 Years
Travel: None
Apply by eMail:15339634.185@jobfrenzy1.com
Apply by eMail:15339634.185@jobfrenzy1.com
Job Created:
Thu Oct 22 2009 04:28:29 AM
Last Modified: Thu Oct 22 2009 04:28:29 AM
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