Clinical Research Project Manager IIPosted: November 12, 2009
We are currently sourcing for a position with our Direct Client and would like to discuss this opportunity with you.
Established in 1995, Rangam Consultants is a multiple service provider in the Information Technology, Scientific, Engineering and administrative fields. We have a proven track record for successfully delivering mission critical consulting, support and recruiting services to various government and Fortune 500 clients.
The details for this position are as follows:
Job Title: Clinical Research Project Manager II
Job Code: RCI-WJNJ-4300
Job location: USROUTE22WEST,SOMERVILLE,NJ
Duration: 12 Months
Start Date: ASAP
JOB DESCRIPTION:
General Summary
Primary responsibility of this position is the initiation and execution of clinical trials that support the business objectives of the venture, both internally and through a CRO. Works under general direction of the Manager, Clinical Operations – SNS Venture.
Principal Duties and Responsibilities (essential functions)
Assists in developing and managing project timelines.
Ensures clinical studies are sufficiently resourced and executed in accordance with project timelines.
Assists in the development of study protocols by coordinating input from various sources: literature, experts, and internal team members.
Reviews Investigator qualifications and performs Site Evaluation Visits for potential study sites, documenting results and recommendations.
Secures consultant and vendor contracts as needed
Implements clinical studies with the CRO, defining and tracking deliverables.
Performs as the primary day-to-day contact with the CRO, study coordinators, and other study vendors as required.
Maintains internal study documentation files.
Tracks invoices/PO’s for periodic financial reporting
Education and/or Experience
Minimum of Bachelor’s degree, preferably in Biological Science, or RN
Minimum 2 years Clinical Project Management experience
Minimum 4 years CRA experience
Medical Device experience preferred
Therapeutic knowledge/experience in urology and/or neurostimulation a plus
Other Required Skills and Abilities
Knowledgeable in GCP guidelines, and FDA/ICH regulations, especially 21CFR 50, 54, 56, and 812.
Skilled in protocol, informed consent, and CRF development
Experienced in study initiation and execution, data management (including EDC), and CRO oversight. Global study experience a plus
Flexibility with changing priorities in a venture environment
Ability to work independently, and as part of a team
Detail-oriented and exceptional organizational ability
Excellent written and verbal communication skills
If interested:
Please provide us the following information:
1) Hourly rate on W2 or expected salary _________
2) Resume in Word format __________
3) Contact information, where we can reach you _________
4) Three professional references with their Name, Company Name, Title and Phone # ________
5) Your Status (Citizen/EAD/Green Card)______
I look forward to hearing from you.
Best regards,
Seema Singh
Rangam Consultants Inc.
Somerset NJ 08873
Direct No:- 908 450 9299 Ext - 312
Alt Phone No: 908 704 8843
Fax: 908 253 6550
Email: staffing@rangam.com
Alt e-mail id: rangamconsultantsinc@gmail.com
WWW.RANGAM.COM
FOR ALL CURRENT OPEN JOBS @ RANGAM CLICK HERE
Message Id : #ID# Please refer to job code RCI-WJNJ-4300 when responding to this ad.
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