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Senior Clinical Project Manager - Freelance

MMS Holdings Inc. is a global pharmaceutical service organization (CRO) that focuses on regulatory submission support for the pharmaceutical, biotech and medical device industries. We are a pharmaceutical service provider supporting pharmaceutical and biotech industries with medical writing, biostatistics, clinical programming, data management, clinical development, regulatory affairs, regulatory submissions and pharmacovigilance.

Our mission is to deliver high-quality services, rooted in good science and decades of regulatory experience, that will assist our clients in developing and marketing life-changing therapies, thereby positively affecting patients' lives worldwide.

Please send your resume and mention your current as well as expected salary.

Project Management

  • Create and execute project work plans and revise as appropriate to meet changing needs and requirements
  • Identify resources needed and assign individual responsibilities
  • Manage day-to-day operational aspects of a project and scope
  • Prepare for engagement reviews and quality assurance procedures
  • Minimize exposure and risk on project
  • Provide project metrics and status reporting
  • Oversee project/program quality and perform project specific training
  • Audit attendance and development of any corrective action plan required
  • Monthly review of project status and updates
  • Responsible for review of compliance metrics
  • Keep current with industry trends, global regulations, and other safety topics
  • ‘Navigator’ for the progression of a portfolio of drug candidates
  • Responsible for leading Governance meetings and overall asset advancement, adhering to defined plan(s)
  • Work across functional teams to coordinate clinical and non-clinical activities
  • Lead discussions to gain team consensus on decision points   

Project Accounting

  • Track and report team hours and expenses on a weekly basis
  • Manage project budget
  • Determine appropriate revenue recognition, ensure timely and accurate invoicing, and monitor receivables for project
  • Follow up with clients, when necessary, regarding unpaid invoices
  • Analyze project profitability, revenue, margins, bill rates and utilization

Client Management

  • Serve as primary contact with customers ensuring customer satisfaction, quality and consistency of operational performance
  • Responsible for initiating customer feedback and responding to feedback
  • Manage day-to-day client interaction
  • Set and manage client expectations
  • Develop lasting relationships with client personnel that foster client ties
  • Communicate effectively with clients to identify needs and evaluate alternative business solutions
  • Seek opportunities to increase customer satisfaction and deepen client relationships
  • Build a knowledge base of each client's business, organization and objectives

Financial and Contract Management

  • Lead contract and budget negotiation efforts
  • Track financial status of assigned projects; assist with or prepare clinical safety-related change orders and invoices
  • Understand our pricing model and billing procedures
  • Assure project legal documents are completed and signed

Business Development

Lead RFP efforts including completing project scoping and costing estimates; Effectively convey our message in both written and verbal business development discussions

Communication

  • Facilitate team and client meetings effectively
  • Hold regular status meetings with project team
  • Keep project team well informed of changes within the organization and general corporate news

Job Requirements

Technical Understanding/ Training 

  • Bachelor's Degree in healthcare or related field. Master's Degree preferred
  • Years of experience required: 7 plus yrs experience in pharmaceutical or healthcare industry
  • Specific experience preferred:5 years of Project Management experience in a pharmaceutical CRO services company
  • Possesses general understanding in the areas of application programming, medical writing and regulatory submissions
  • Understands Internet, Intranet, Extranet and client/server architectures
  • Maintains awareness of new and emerging technologies and the potential application on client engagements

Teamwork

  • Consistently acknowledges and appreciates each team member's contributions
  • Effectively utilizes each team member to his/her fullest potential
  • Motivates team to work together in the most efficient manner
  • Keeps track of lessons learned and shares those lessons with team members
  • Mitigates team conflict and communication problems
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