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Project Manager II (CRO or Life Sciences) - Remote

Project Manager II (CRO or Life Sciences) - Remote

MMSDenver, CO, US
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About MMS MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges.

With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating.

Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide.

MMS recognizes that a talented staff is what drives our business forward.

Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission.

At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger. For more information, visit  www.mmsholdings.com  or follow MMS on  LinkedIn .

This position requires proven Project Management experience in supporting marketing applications, as well as in the development and management of Risk Evaluation and Mitigation Strategies (REMS) programs.

Responsibilities :

  • Understands various cost models and develops budgets for moderate complexity projects.
  • Ensures financial KPIs are achieved on assigned projects; invoices on-time and ensures alignment with the contracted payment schedule; updates revenue projections on assigned projects.
  • Controls project scope via defined PM methodology and processes for change management.
  • Develops moderate complexity project timelines independently.
  • Performs advanced functions in MSP.
  • Understands task constraints and conveys critical path milestones to the functional lead.  Develops / input into strategies to help achieve timeline expectations.
  • Executes day-to-day activities during the course of a program / project including risk identification, issue escalation and resolution.
  • Collaborates with functional line management to resolve any issues and trends.
  • Intermediate excel skills (Hlookup, Vlookup, Pivot Table, etc.).
  • Drives customer satisfaction and works to strengthen client relationships.
  • Develops an account growth plan and consults with line manager to achieve a 10% revenue growth annually (minimum).
  • Manages minimum one key account.
  • Participates in or leads RFIs / RFPs in collaboration with proposals team.
  • Participates in or leads capabilities meetings - at least 2 annually.
  • Participates in or leads bid defenses - at least 1 annually.
  • Proficient in Word, Outlook, PowerPoint.
  • Proficient in meeting facilitation including scheduling, development of agendas and meeting minutes; works with project leads to ensure meeting objectives are met.

Understands general requirements :

  • ICH, 21CRF Part 11, and ISO 9001 : 2000.
  • Responsibilities :

  • Bachelor’s Degree required, or relevant work experience.
  • Minimum of 5 years’ experience in project coordination or project management or similar field required.
  • Expert knowledge of scientific principles and concepts.
  • Proficiency with MS Office applications.   Hands-on experience with clinical trial and pharmaceutical development preferred.   Good communication skills and willingness to work with others to clearly understand needs and solve problems.    Excellent problem-solving skills.   Good organizational and communication skills.   Familiarity with current ISO 9001 and ISO 27001 standards preferred.  Familiarity with 21 CFR Part 11, FDA, and GCP requirements.   Basic understanding of CROs and scientific & clinical data / terminology, & the drug development process.
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