- Education: N/A
- Functional Area: Health Care & Medical
- Industry: Medical/Healthcare/Hospital
Job Title : MDR Coordinator
Location : Mansfield, MA
Duration : 24+ Months Contract
· Member of the Medical Affairs team responsible for coordinating activities essential to the timely execution, quality control, maintain database and archiving documents.
· This position is responsible for input and tracking of projects and organizing internal update meetings.
· Responsible for the generation and tracking of Medical Affairs invoices, PO and payments, and assisting with contracts and other essential activities associated with the management of projects.
• Project Functions:
o Maintain and update spreadsheets tracking the status for CER projects
o Work with the manager to schedule meetings and keep track of the progress and outcomes of the projects.
o Work closely with the Sr. Directors, managers and medical writers to schedule meeting to kick off new projects, update changes with team on the projects.
o Responsible for the coordination of projects by following established SOPs. Collaborate with other Coordinators/ key stakeholders to ensure that projects are coordinated and tracked in a standardized way.
o Accountable for maintaining project activity tracking through meetings and associated tracking spreadsheet.
o Responsible for tracking contract development and execution.
o Maintain effective communication with other departments to determine trial status and scheduling.
o Maintain project schedule tracking.
o Assist in the development and execution of meetings between internal and external constituency.
o Responsible for collecting, maintaining, archiving and retrieving all documents necessary to ensure compliance with SOP
o This is managed by the compliance team Document Control Specialist develops and maintains a comprehensive hardcopy and online filing system and computer database for all documents to be retained in the document control center.
o Manages the operation of the document control center to ensure that all users have the latest version of appropriate documentation in a timely manner.
• Financial Functions:
o Accountable for tracking budget documentation.
o Accountable to assemble and maintain reliable documentation to develop annual, quarterly and monthly Latest Estimate (LE) budgets for Finance.
Department specific/non-essential functions:
• Other duties as assigned with or without accommodation.
Education required/ preferred: Bachelors Degree
Preferred Skills/Qualifications: Bachelor's Degree in health profession or business related field. Experience in medical device and/or pharmaceutical preferred.
Knowledge of international regulations for pre-clinical and clinical studies preferred.
Skills/Competencies: Ability to speak, write and understand English to comply with written procedures, instructions, SOPs and other documents.
Excellent organizational skills.
Effective written and verbal communication skills in the area of technical/clinical applications.
Effective analytical and problem solving.
Ability to coordinate multiple projects simultaneously.
Effective skills in MS Excel, PowerPoint, Word and internet search engines (including SharePoint creation and management).
Other Skills: Ability to work with a minimum of supervision.
Ability to work in a team environment.
• Position reports directly to manager
• This position will work closely with all levels of the Medical Affairs department as well as other departments including CA, RA, QA, PMV, Marketing, Legal, Finance, Accounts Payable, PMO and R&D.
• Normal office working environment
• Some travel may be required
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Select Source International is a Global Solutions provider of IT staffing and Project services. Our service offering has 5 main practices; ERP, Application Development, Middleware, Database Management and Project Services. SSI offers industry leading Data Migration, Compliance, and Risk Management through its subsidiary Data Wave. Data Wave offers Cyber Security and risk management through a GRC product suite called Risk Utilities. In addition to our technology offerings, SSI also provides administrative and business consulting services. Industry Experience: Retail Healthcare Manufacturing Energy and Utilities Government Financial Engineering.
- Name: Mukesh Sharma
- Email: email@example.com
- Phone: 9525463300
- Extension: 6003
- Name: Select Source International
- Website: www.selectsourceintl.com