Clinical Manager – NJ – 2452075
Location: Northern New Jersey
Description: Valesta is in need of Clinical Manager – NJ – 2452075 right now, this job will be placed in New Jersey. More complete informations about this job opportunity please read the description below. Title: Clinical Manager â€" NJ â€" 2452075
Company: Pharmaceutical Company
Location: Northern NJ
Status: Full-t! ime Consulting Engagement, 40 hours/week
Length: Long-term consulting engagement in 6 month increments
Our client is one of the largest pharmaceutical companies in the world and voted as one of the 100 Best Companies to work for by Working Mother Magazine. They are committed to peak performance, improving the quality of life, and embracing and leveraging diverse backgrounds, cultures and talents to achieve competitive advantage.
Responsibilities:
Serves as Clinical Trial leader and assists other Clinical Trial Leaders.
Contributes to continuous improvement process.
Prepares Clinical Trial Protocol Summaries and Clinical Trial Protocols.
Makes recommendations regarding monitoring safety, eligibility, enrollment and data consistency.
Prepares Draft Clinical Trial Reports and Draft Summaries and various registration documents.
Provides clinical research expertise in support of other depar! tments and line functions.
Preparation and implementa! tion of project specific training programs and training materials for internal and external staff.
Participates in multidisciplinary task forces in support of continuous improvement and other management objectives.
Demonstrates ability to write, study related procedure manuals, patient informed consents, and manuscripts.
Design clinical trials.
Outsourcing selection and management including CRPs, SMOs, central labs, and other central services as dictated by the protocol.
Design CRFs.
Site selection, site management (interacts effectively with investigators and study coordinators).
Ability to assist sites with patient recruitment goals.
Draft and negotiate contracts.
Identify study responsibilities (SSW) per department and per company, in-house vs. CRO.
Draft clinical trial budgets.
Track progress of clinical trial.
Proactive in relation to study needs, such as anticip! ating and meeting timelines and budgets.
Liaise with all involved departments/line units.
Support GTL in ensuring all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards: development of study tools and guidelines to ensure consistency in study implementation and management at site, management of clinical study material, implementation of issue resolution plan.
Support GTL in preparation of clinical outsourcing specifications and in the follow up with day to day operation with vendors.
Support GTL in the management of the trial master file.
Support GTL in managing interactions with the clinical trial team and CPOs.
May assist GTL in management of trial allocation and coordination of activities leading to site initiation.
Support Medical Lead/CS/GTL by generating periodic data cleaning reports as assigned.
Support the GTL in trial close out a! ctivities.
Participate in clinical trial team meetings.
Skills:
Minimum of 1-3 years applicable experience.
Demonstrated written and verbal communication skills.
Medical/scientific writing skills.
Demonstrated ability to write protocols and Clinical Trial Reports.
Possess good presentation skills.
Facility with computer software in Word, Power Point and Excel.
Ability to recognize safety and efficiency data trends.
Knowledge of clinical trial design, statistics and pharmacokinetics.
Familiar with all aspects of the drug development process.
Knowledge of the medical, scientific and clinical research techniques of the assigned area. Knowledge of GLP and local regulatory requirements.
Exhibits team leadership skills.
Education:
Universit! y/Nursing degree
Higher degree would be preferable
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If you were eligible to this job, please email us your resume, with salary requirements and a resume to Valesta.
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This job starts available on: Tue, 16 Apr 2013 12:25:21 GMT