Scientific Jobs

Exodon is an international clinical research organization. Our home office is in the United States in northwestern New Jersey and we have offices in India, the Philippines, and Argentina. We specialize in patient recruitment services. Our clients are study sponsors and CROs. We match the medical record data from patients in our databases and refer these patients to our clients study centers conducting the clinical research trials. We also have our own international network of clinical research sites. When needed, we provide clinical research site support services to the doctors (investigators) at these sites.

We are interviewing CRAs and CRCs for Senior/Central Project Manager to manage clinical trials contracts where we provide trial management organization (TMO) and site management (SMO) services to our VALIDATE System® network of sites. Although our sites and patients are globally based most of the studies take place in the US.

Primary Responsibilities
Manage ongoing clinical trials at our network sites. This includes coordinating international per diem and regional site support services at our sites in our VALIDATE System® network. Each Central PM will be responsible for an average of 6-8 projects. The number of sites per project can vary. For sites being managed by Exodon’s SMO division - CRpartners the range is typically 1 - 5 sites. For patient recruitment contracts the range of sites is typically much higher from 5 to >100, but the Central PM only manages the sites we enroll into the trial not the sponsor sites.

You will be responsible for:
• Implementing site initiation services for upcoming contracts at our sites which are internationally based,
• Submitting Site and Patient Identification reports to our clients to facilitate site selection,
• Submitting weekly pre-consent patient recruitment reports to our clients to facilitate site selection,
• Educating sites on Exodon’s clinical research model leading with our proprietary patient recruitment services,
• Contracting, assigning and supervising regional clinical research staff,
• Writing Study Plans
• Coordinating with our Clinical Research Service Consultants (CRSCs) who work in marketing and sales to move each site to the pre-screening phase,
• Ensuring patient recruitment goals are met
• Conducting weekly team conferences with Exodon CRSCs,
• Conducting weekly team conferences with Exodon regional teams,
• Managing all regulatory documents and processes for our VS sites,
• Ensure studies are being conducted according to GCP/ICH guidelines
• Provide weekly quality assurance of the eCRFs
• Managing contracts and budgets with sites,
• Managing and closing out on-going contracts and,
• Coordinating with Accounting to ensure accurate invoicing of our clients

There are also opportunities to conduct internet based clinical research training programs using our proprietary GCP/ICH training programs for our new investigators and clinical research staff around the globe (10% or < of job responsibilities). Per diem related duties might be assigned by the Director of Clinical Research as all Sr/Central PMs report to this position. Qualifications Candidates must be energetic and entrepreneurial minded with exceptional interpersonal skills and seek to play a vital role in growing a clinical research organization. Innovative skills are critical, but the candidate must be both process and detail oriented and be able to fluidly communicate their thoughts and strategies to others. Candidate must be fluent in English. Fluency in other languages is a strong asset. Candidates must have a strong clinical research background with certification training in GCP/ICH as well as experience in following SOPs and knowledge of US CFRs. You must be proficient in MS Office, internet and database searching. College education in science needed such as a BS, preferably with additional certification as a CRC or CRA training. MD and RNs backgrounds also welcomed as long as the candidate has the above mentioned credentials in clinical research Candidates must have at least 5 years clinical research experience in one or more of the following areas: project, trial or study management for the Senior Central Project Management Position and at least 3 years for the Central Project Management position. Prior experience in monitoring, coordinating, and regulatory affairs is also preferred. This is an exceptional position for the individual seeking to develop their clinical research career with opportunity for advancement into management and ultimately executive positions. Candidates will only be considered who meet or exceed the above reviewed qualifications so please do not forward CV if you do not meet criteria for this position. Ideally we are looking for someone who will ultimately develop into a potential executive in our company. Compensation Competitive base salary and allowances Lucrative bonus package Exceptional opportunity for corporate advancement Pre-IPO company equity via stock options Medical, Disability, and Company Matched Retir

Date: 29 March 2008
City/Town: Manila
Location: Manila
Wage/Salary: commensurate to qualification
Start: March 28, 2008
Duration: April 30, 2008
Type: Full Time
How to apply: send resume by e-mail
Company: Exodon
Contact: Mr. Edmund Yang
Email: