Miscellaneous Clinical
Location: King of Prussia Pennsylvania
Description: Randstad Pharma is employing Miscellaneous Clinical right now, this career will be placed in Pennsylvania. For detail informations about this career opportunity please read the description below. Position Description
Assist with implementing the process for global feasibility to help teams in the targeted identification and selection of regions/countries/sites aligned with th! e program CDP strategy, timelines and budget
Position Responsibilities
Utilize and adapt templates, tools and metrics
Assist in the training of study teams on tools and templates
Interface with Clinical Operations and Strategy & Development to create global disease roadmaps, web-based feasibility surveys, enrollment forecasts, and documented enrollment and risk mitigation plans
Utilize prior experience, country regulatory approval timelines, tools (TrialTrove, Citeline, ct.gov, literature) KOL and vendor data to build and analyze enrollment projections and advise teams
Create enrollment scenarios using Study Optimizer using historical, feasibility and epidemiology data
Assist with vendor liaison to facilitate timely feasibility process to expectations
Analyze and recommend optimal country mix to successfully meet enrollment targets and commercial needs
Provide Global Leadership Team with update! s on country/site feasibility, status of timelines, risk and m! itigation strategies for upcoming studies and country level performance
Assist with the management of patient recruitment efforts across all TAs
Assist teams to develop enrollment timelines based upon regulatory approval information, site initiations, historical and competitive trial data
As appropriate, utilize patient recruitment vendors and advocacy groups to assist with site support and patient recruitment across TAs.
Assist teams in motivation and early intervention of non-productive sites
Working relationships:
Position Requirements
A degree (BS/MS or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred)
Other degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist)
a minimum of 3+ years relevant clinical researc! h (or related) experience within the pharmaceutical industry
A solid understanding of the drug development process, and specifically, each step within the clinical trial process
Experience in overseeing global clinical trials (pharmaceutical or research institute)
Experience managing and influencing global feasibility and recruitment including knowledge of, and prior experience, using processes and tolls to achieve desired results
Experience using enrollment forecasting software (e.g. Study Optimizer) to create and adapt study enrollment simulations.
Experience with Clinical Trial Management Systems (e.g. IMPACT) and other technology as appropriate (e.g. Mapviewer)
Strong knowledge of Microsoft Office (Excel, Power point, Word)
Global experience and understanding of different country regulations and timelines to provide strategic input to country selection
Budget forecasting and management
Thor! ough knowledge of ICH guidelines/GCP and its applicability to all stage! s of the clinical development process
Knowledge and use of project management software packages
Knowledge and use of enrollment forecasting software packages (e.g. Study Optimizer).
Knowledge and experience using literature, prior data, tools (TrialTrove, Citeline, ct.gov, etc) to drive feasibility and enrollment projections and timelines
Experience in scientific/medical research
Demonstrated ability to plan and ensure execution and completion of clinical study to the highest ethical and scientific standards to lead teams and work in a fast paced team environment
Experienced in working in a matrix environment
Excellent interpersonal and decision making skills. Demonstrates innovation. Possesses drive, energy and enthusiasm to deliver the program objectives. Understanding of tasks involved in a clinical study from developing a protocol through the finalizing a clinical study report and criticality of robust site ! selection and recruitment timelines
Comprehensive knowledge of ICH guidelines/GCP. Maintains current medical/scientific/regulatory knowledge
Demonstrated Project Management skills including simultaneous management of multiple studies. Possesses excellent planning, time management and coordination skills
Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements interactions with external parties, timelines, and complex clinical studies.
Excellent written and oral communication skills
Maintains computer literacy in appropriate software (Excel, Word, Power Point, Project, Study Optimizer, Mapviewer)
Benefits
Medical, Dental, and Vision Insurance
401K Plan with Company Match
Flexible Spending Account
Life and AD&D Insurance
Relocation Assistance
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If you were eligible to this career, please email us your resume, with salary ! requirements and a resume to Randstad Pharma.
If you interested on this career just click on the Apply button, you will be redirected to the official website
This career starts available on: Wed, 05 Jun 2013 19:30:23 GMT
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