Senior Clinical Project Manager

4 weeks ago


Framingham, United States Alira Health Full time

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary
At Alira Health, our mission is to enable healthcare transformation. Our team collaborates fully to understand every aspect of each client's organization from concept ideation to commercial realization, from innovation to implementation. We support our clients with a full spectrum of patient-centric data and tech-enabled services including Transaction Advisory, Management Consulting, Real-World Evidence, Advanced Analytics, Patient Engagement, Product Development, Regulatory, Clinical, and Market Access.
Our clients are global, and so are we. Our local presence and global collaboration allow us to deliver actionable business insights and an unmatched continuum of support across the full corporate and product lifecycle. We operate across thirteen offices located in Boston and San Francisco in the US; Barcelona, Basel, Bologna, Geneva, Milan, Munich, Paris, and Verona in Europe; Cambridge, United Kingdom; Sydney, Australia; and Toronto, Canada.

Job Description

The Sr. Clinical Project Manager (SCPM) is an important member of the Alira Health Clinical team. The SCPM ensures the efficient implementation of study protocols, works closely with all Clinical team members, and communicates directly with study sponsors and vendors.

ESSENTIAL JOB FUNCTIONS*
•Manages clinical research studies to ensure studies are conducted in accordance with approved scope of work/budget, ICH GCP guidelines, and FDA regulations and within established timelines
•Serves as study lead and primary contact for sponsors
•Manages clinical study functions, which may include investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and central laboratory
•Generates and presents frequent study status updates and reports to sponsor
•Supervises and provides support to the Clinical team, including Clinical Assistants, In-house Clinical Research Associates, and Clinical Research Associates
•Supervises and trains Associate CPMs and provides ongoing support and high-level guidance to CPMs
•Creates and reviews clinical study documents, including protocols, ICF templates, study budgets, site log/form templates, study manuals and plans, site binders, etc.
•Drives and facilitates clinical teamwork and communications to ensure timely attainment of trial milestones
•Ensures accuracy of reports and material work product
•Provides monthly billing information to finance team
•Presents at project meetings such as investigator meetings and new client meetings
•Updates management accurately and regularly through frequent communication
•Identifies issues and develops problem-solving strategies to ensure study timelines are met
•Manages subject accrual, retention, and compliance
•Assists in TMF management and manages TMF reviews as needed
•Prepares for and participates in third-party audits and FDA inspections
Alira Health - Sr. Clinical Project Manager Page 2 of 2
Version: March 2023
•Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company SOPs
•Participates in internal, client/sponsor, scientific, and other meetings as required
•Performs additional duties as assigned

PREPARATION, KNOWLEDGE, SKILLS & ABILITIES
•BS/BA from an undergraduate program (life sciences or related discipline preferred) or equivalent experience
•10 years of experience in the pharmaceutical / biotechnology / CRO industry with at least 5 years of clinical project management experience
•Proven ability to be careful, thorough, and detail-oriented
•Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment
•Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
•Self-starter who thrives in a collaborative, yet less structured team environment
•Ability to problem-solve unstructured or ambiguous challenges
•Strong command of English, both written and verbal
•Excellent communication and interpersonal skills with customer service orientation
•Proficient with MS Office Suite, particularly Word and Excel
•Permanent authorization to work in the U.S.

Languages

Education

Contract Type
Regular



  • Framingham, United States Sincere Corporation Full time

    Job DescriptionJob DescriptionSincere is looking for a Senior Software Project Manager to join our growing team. The ideal candidate has 5+ years of experience as a key member of a product team and has delivered a wide range of software applications to market. The Senior Project Manager will ensure smooth project execution across UX, engineering, and QA. In...


  • Framingham, Massachusetts, United States Sincere Corporation Full time

    Sincere is looking for a Senior Software Project Manager to join our growing team. The ideal candidate has 5+ years of experience as a key member of a product team and has delivered a wide range of software applications to market. The Senior Project Manager will ensure smooth project execution across UX, engineering, and QA. In this role, you will provide...

  • Senior Data Manager

    3 weeks ago


    Framingham, United States Alira Health Full time

    Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Job Description...


  • Framingham, United States Creative Cove Inc. Full time

    Our Metrowest retail client is looking for a Creative Project Manager with 3+ years of experience. This role is onsite 2 days a week and a year long contract to start. Looking for experience as a Traffic, Project or Marketing Project Coordinator in either an agency or in house agency setting and ideally looking for experience in the retail, CPG or fashion...


  • Framingham, United States Creative Cove Inc. Full time

    Our Metrowest retail client is looking for a Creative Project Manager with 3+ years of experience. This role is onsite 2 days a week and a year long contract to start. Looking for experience as a Traffic, Project or Marketing Project Coordinator in either an agency or in house agency setting and ideally looking for experience in the retail, CPG or fashion...


  • Framingham, United States Creative Cove Inc. Full time

    Our Metrowest retail client is looking for a Creative Project Manager with 3+ years of experience. This role is onsite 2 days a week and a year long contract to start. Looking for experience as a Traffic, Project or Marketing Project Coordinator in either an agency or in house agency setting and ideally looking for experience in the retail, CPG or fashion...


  • Framingham, United States Staples Full time

    Job Description Staples is business to business. You're what binds us together. Our eCommerce team delivers customer-centric site experiences to position Staples as a digital selling platform of choice. Our team ensures that our mobile, desktop, and app platforms deliver the digital experience that our customers expect. We do this through customer insights,...

  • Project Manager

    1 week ago


    Framingham, United States DPS Group LLC Full time

    Summary The project manager plans and organizes all architectural and engineering functions specific to each project, coordinates interaction between project teams and clients, and provides guidance on technical resource loading. The successful candidate must have a strong design discipline background along with experience managing architectural and...


  • Framingham, United States Staples, Inc. Full time

    Staples is business to business. You’re what binds us together. Our merchandising team aims to deliver the best value and selection to our customers through products, services and solutions all centered around our customers’ needs. We are driven by customer insights and analytics to bring products and solutions to market seamlessly. We’re inclusive,...


  • Framingham, United States Staples Full time

    Staples is business to business. You're what binds us together. Our digital solutions team is more than a traditional IT organization. We are a team of passionate, collaborative, agile, inventive, customer-centric, results-oriented problem solvers. We are intellectually curious, love advancements in technology and seek to adapt technologies to drive Staples...

  • Project Specialist

    1 week ago


    Framingham, United States AllSTEM Connections Full time

    My client a major retail company is seeking a Project Specialist to join their team for a 4+month temporary position at their location in Framingham, MA. Major Areas of Responsibility: Strategically plan and manage a high volume of projects annually (400-600) within an existing marketing process. Manage the workflow of multiple projects simultaneously...

  • Project Specialist

    17 hours ago


    Framingham, United States AllSTEM Connections Full time

    My client a major retail company is seeking a Project Specialist to join their team for a 4+month temporary position at their location in Framingham, MA. Check you match the skill requirements for this role, as well as associated experience, then apply with your CV below. Major Areas of Responsibility: Strategically plan and manage a high volume of...

  • Project Specialist

    2 weeks ago


    Framingham, United States AllSTEM Connections Full time

    My client a major retail company is seeking a Project Specialist to join their team for a 4+month temporary position at their location in Framingham, MA. Major Areas of Responsibility:Strategically plan and manage a high volume of projects annually (400-600) within an existing marketing process.Manage the workflow of multiple projects simultaneously through...

  • Project Specialist

    6 days ago


    Framingham, United States AllSTEM Connections Full time

    My client a major retail company is seeking a Project Specialist to join their team for a 4+month temporary position at their location in Framingham, MA. Major Areas of Responsibility:Strategically plan and manage a high volume of projects annually (400-600) within an existing marketing process.Manage the workflow of multiple projects simultaneously through...

  • Senior Accountant

    5 days ago


    Framingham, United States Berg Health Full time

    POSITION SUMMARY: The Senior Staff Accountant will cover monthly close activities with a focus on accounting for outsourced vendor contracts for clinical areas. The individual will collaborate with the Accounting Manager on a variety of projects and activities, including support of the annual audit and assisting with strategic and functional initiatives....


  • Framingham, United States Staples, Inc. Full time

    **Staples is business to business. You’re what binds us together.** Our world class sales and sales support teams work directly with businesses of all sizes to offer products and services to meet our customers’ unique needs. We are committed to understanding our customers and use best-in-class sales tools and technology to find the best solutions....

  • Food Service Director

    3 weeks ago


    Framingham, United States Benchmark Senior Living Full time

    Job Description The Branches of Framingham is looking for a passionate and skilled Director of Food Service! Joining the Benchmark Senior Living team means putting your passion to work. Our associates feel a sense of belonging with the care that they provide, empowered by the open and reliable team that surrounds them. Our diverse and skilled workforce...


  • Framingham, United States Staples Full time

    Staples is business to business. You're what binds us together. Our world class sales and sales support teams work directly with businesses of all sizes to offer products and services to meet our customers' unique needs. We are committed to understanding our customers and use best-in-class sales tools and technology to find the best solutions. We're...


  • Framingham, United States Staples, Inc. Full time

    Work with functional leads and others as needed to understand business requirements and transform raw data into actionable and meaningful insights. Develop quality reporting tools/products to extract valuable business insights. Work with Business Int Project Manager, Operations, Sales, Manager, Project, Business, Retail, Business Services


  • Framingham, Massachusetts, United States Ameresco, Inc. Full time

    Ameresco is seeking a highly skilled and experienced DDC (Direct Digital Controls) Controls Project Manager to oversee and manage our DDC controls projects around Tampa, FL. As a DDC Controls Project Manager, you will be responsible for leading the planning, execution, and successful completion of multiple projects related to building automation and controls...