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Clinical Research Scientist II (3951354)

Company Name:
Artech Information Systems, LLC
Reference # : 14-19785 Title : Clinical Research Scientist II (3951354)
Location : East Hanover, NJ
Position Type : Contract
Experience Level : Start Date / End Date : 06/30/2014 / 12/30/2014
Description
Job Title: Clinical Research Scientist II (3951354)
Location: East Hanover, NJ
Duration: 6 Months
No. of Positions: 4
Company: Artech Information Systems LLC.
Client: A Leading Pharmaceutical Organization
Job Description:
Support the development of operational plans for clinical deliverables, effectively applying principles of design excellence:
o Contribute to the development and review of Clinical Development Plan (CDP) with focus on operational aspects including other develop program level plans to support project level allocation, outsourcing strategy, and monitoring committees that may require Board review. Support the development of the Operational CDP (O-CDP)
o Create trial concept sheet.
Accountabilities:
Responsible to lead operational excellence in the CSU and scientifically supports CSU by ensuring development of program quality standards (e.g. collation of synopsis/protocols/CDP reviews, provide scientific/medical input, advisory boards, education activities).
Support development and implementation of disease/program standards within CSU.
Support Medical Lead with the development of program level documents, including clinical sections of regulatory documents (e.g. Investigators' Brochures, briefing books, submission dossier, and responses to Health Authorities questions).
Responsible for execution of assigned clinical deliverables within approved budget.
Lead the clinical trial protocol development process by independently translating the Clinical Development Plan strategy and approved trial concept sheets into efficient, high quality, executable clinical protocols and related documents:
o Seek external (e.g. KoL, regulatory authorities, patients associations) and internal (e.g. CSU, CPO Medical Advisors) medical/scientific input
o Align input with other line functions
o Drive science by incorporation of innovative designs
o Obtain approval from internal review boards
o Ensure trial implementation according to protocol
Scope of Work:
In collaboration with Trial Statistician, develop Reporting and Analysis Planning (RAP) modules in line with program standards.
Responsible to drive development and implementation of relevant data capture tools in collaboration with GTL and IIS as documented in data handling plan or equivalent document (e.g. CRFs, protocol deviations, questionnaires, diaries, translations, edit checks)
As agreed with Medical Lead, manage all trial related committees (e.g.., Data Monitoring, Adjudication) including decision making around key parameters to monitor and report; preparation of charters and data for review; manage committee meetings/reviews timelines; and provide regular updates to Safety Management Team and other clinical boards.
Responsible for the ongoing review of clinical trial data as outlined in the data handling plan or equivalent, supports GTL to prepare database lock; and perform data reconciliation.
Collaborate with Medical Lead/BSL to identify any safety trends; and as needed, reports on trial data to safety and clinical boards (e.g. SMT, GCT, GPT).
In collaboration with Medical Lead, responsible for final analysis and interpretation of results including the development of clinical trial reports, publications, and internal/external presentations.
Responsible for implementation of best practices and standards for trial management within the franchise, including sharing lessons learned.
May serve on or lead global process improvement work streams or act as Subject Matter Experts for training or SOP.
Required Experience:
Timely delivery of quality documents to support the Clinical Development Plan (e.g. concept sheets, executable synopses); as well as clinical component of regulatory documents
Effective risk management in design of trial synopses/protocols
Efficient and timely execution of the trial protocol and related documents in collaboration with GTL, in compliance with international and local regulations and Client's internal standards
Demonstrates excellent scientific writing skills to enable the development of quality clinical protocols, trial reporting, and regulatory documents (no avoidable amendments)
Submission of quality documents at Final Protocol Package (e.g. protocol, ICF, clinical sections of the CTA)
Applies effective clinical research methodology, including trail design/analyses, efficacy endpoints, safety assessments across disease area and development phases
Data cleaning & review process is successfully accomplished within the required timelines across the trial with 100%25%20clean data and no database unlocks
Skills:
Fluent English (oral and written)
>= 4 years technical and operational experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organisation.
Manage several trials in parallel with multidisciplinary trial teams in a matrix organization
Strong interpersonal skills
Ability to work under pressure
Excellent negotiation and conflict resolution skills
Resolve issues with minimal supervision and understand when to escalate
Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process.
Demonstrates excellent scientific writing skills
Knowledge of the assigned therapy area is desired, with the capability to interpret, discuss and represent trial or program level data.
Demonstrates knowledge and application of statistical analysis methodology and can identify trends and interpret / report data effectively
Education:
Advanced degree (or clinically relevant degree) in life sciences/healthcare is required.
PharmD, PhD preferable.
Thanks,
Wajid Khan
Lead Recruiter- Core Staffing
240 Cedar Knolls Road, Suite 100 - Cedar Knolls, NJ 07927
Office - Fax
Email: wajid. - Website:
Artech is the #10 Largest IT Staffing Company in the US!
About Artech Information Systems LLC
Artech is an employer-of-choice for over 5,800 consultants across the globe. We recruit top-notch talent for over 65 Fortune and Government clients coast-to-coast across the U.S., India, and China. We are one of the fastest-growing companies in the U.S. and this may be your opportunity to join us!
Want to read more about Artech?
Clickhereto visit our website or click on the following links to read what others are saying about us:The Wall Street Journal,Forbes (1)(2),BusinessWire,Entrepreneur,Better Business Bureau,Hoovers,Diversity Careers(1)(2),The Artech Circle,NJTVOnline,The Business Forum Show, andSIA: "Above the Crowd."
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