Previous Job
Previous
Project Manager II - CLINICAL
Ref No.: 18-45656
Location: Cambridge, Massachusetts
Start Date / End Date: 09/10/2018 to 12/31/2018
Job Description:
Job Title: Project Manager II
Job ID: 18-45656
Location: Cambridge, MA
Duration: 4 Months
Job Description:
The ISS Project Manager is responsible for the overall management and activities of Investigator Sponsored Studies (ISS) for assigned drug programs globally. The ISS Project Manager is responsible for ensuring these studies are run in compliance with GCPs, SOPs and local regulations. The role includes managing the Scientific Research Committee (SRC) meetings for the purpose of reviewing and approving ISS protocols submitted by external parties. The ISS Project Manager is responsible for overseeing and managing the timely execution of contracts and financial payments, budgeting and financial forecasting in client’s finance systems, tracking ISS study progression, managing the ISS database, and for maintaining ongoing metrics and reports on a regular basis. This position liaises with the Global Medical Directors responsible for the drug program and with various other members of the Scientific Review Committee (SRC), internal finance teams, legal representatives, Medical Science Liaisons, Country Medical Directors, Senior Leadership, and with ISS contacts globally.
Responsibilities include:
  • Manage and organize SRC meetings. Manage ISSs through the approval and contract negotiation stages
  • Work with Regulatory Affairs to generate cross reference letters and ensure all regulatory documents for studies are in place
  • Responsible for generating contracts and CDAs with Legal
  • Responsible for forecasting study drug requirements to CPRS group and arranging for shipping and monitoring of study drug supply
  • Responsible for forecasting ISS milestone payments via an accrual methodology in Genzyme’s financial tracking tool
  • Responsible for corresponding with sites to provide updates on ISS status pre-approval
  • Maintain communications with client Pharmacovigilance for drug safety updates and distribute formal update letters to investigator sites as needed
  • Distributing Investigator Brochures (IB)
  • Communicating with GMO senior management, Medical Directors, global colleagues and MSL team regarding study updates
  • Responsible for preparing Purchase Orders (POs) and managing invoices. Training of SRC members and Medical Science Liaisons (MSL) on VisionTracker (database software)
  • Ensure ISS records and history are audit ready. Responsible for maintaining an efficient, compliant global ISS process that includes a continuous improvement plan
  • Support data quality check, Support in data entry process and data quality improvement, Support data extraction for Safety reporting and audit/inspection, Support in Vision Tracker evolution project
 
Knowledge and Skills:
  • Project management skills
  • Working knowledge or clinical development, FDA regulations and ICH/GCP guidelines
  • Ability to work in an international environment
  • Understanding of database concepts
  • Knowledge of industry standards and practices preferred
Education:         
  • Bachelor Degree in business or science area with 3+ years pharma/biotech industry experience in clinical research or medical affairs.
  • Track record of successfully managing multiple complex projects from start to completion.
Other required skills and attributes:
  • Experience in managing budgets and forecasts
  • Demonstrated superb organizational, time management and communication skills (verbal and written)
  • Demonstrated experience working on multiple global projects simultaneously
  • Strong interpersonal skills with the ability to interact with all levels of the organization
  • Clinical trial management experience preferred.
Please apply on our company website (www.artechinfo.com) with reference to job ID, or contact me at nisha.samuel@artechinfo.com / 973.967.3540
 
Thanks,
Nisha Samuel
Assistant Manager- Staffing

Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.967.3540 | Fax: 973.998.2599
Email:nisha.samuel@artechinfo.com| Website:
www.artech.com
Artech is the #1 Largest Women-Owned IT Staffing Company in the US!

Connect with us on - LinkedIn | Facebook | Twitter