Senior Project Coordinator

Full-time

Position Summary:

The Senior Project Coordinator is responsible for assisting the Project Management team as assigned, with the responsibilities relevant to contracted projects/studies.

Scope & Impact:

This position supports the Project Management team in tasks required by the study protocol and contract to ensure adherence to quality and study timelines.

Major Responsibilities:

  • Serve as back-up to project managers and take on individual project assignments as necessary to support the business
  • Support for managing project specific financials (revrec, change orders, budgets)
  • Support Project Manager in conducting the kick-off meeting and other study team meetings with internal and external study team members
  • Regularly review the status of site qualification, image processing and query management to meet study timelines
  • Coordinate with site/center qualification team with providing site contact lists and helping with determining the readiness and prioritization with setups
  • Alert the project manager of any resourcing or timeline issues
  • Assist with managing the data reconciliation process
  • Interact with the reader management team and provide read status to Project Managers
  • Support Project Management meetings by taking and distributing meeting minutes
  • Develop and distribute weekly trackers as required for internal and external distribution
  • Provide eligibility confirmation and approvals to scan to sites, to include qualification reports
  • Support iCRO To Do report for upcoming deliverables
  • Support development of study documents (e.g., Electronic Technical Binder, Communication Plan, Project Plan)
  • Supporting site set-up and dose ordering, as applicable
  • Support distribution of training materials
  • Act as back-up by interfacing with external and internal teams in Project Manager’s absence
  • Perform other duties as assigned by supervisor

Qualifications:

  • Associates Degree; Bachelor Degree (preferred)
  • Strong communication skills
  • Clinical trial experience preferred
  • Medical Imaging experience preferred
  • Excellent grasp of SOPs
  • Excellent organizational skills
  • Detail oriented
  • Experienced in Microsoft Office tool set
  • Exhibits ability to exercise good judgment

Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.

Medical Writing Manager

Full-time

Position Summary:

The Medical Writing Manager will develop, create, edit, and coordinate the production of image review charters and reader manuals, technical operations manuals and other critical study documents that may or may not be associated with submission to a regulatory agency.  This development includes the management of a library of reusable text based on therapeutic area, analysis methods and other relevant criteria.  In addition, this role and associated staff will be support the development of templates of imaging documents as requested by operations leadership. The Manager is responsible for all line management of assigned medical writing staff as well a project prioritization with input from operations leadership.

Scope & Impact:

This position works with internal project teams and external stakeholders to develop the necessary language to support the development of charters, reader manuals and imaging operations templates.  The manager will bring structure to the development and tracking of these critical documents and well as reusability of language to efficiently develop these documents in a timely manner.

Major Responsibilities:

  • Author Imaging Charters based on details pulled from the study protocol and in collaboration with sponsor teams based on regulatory guidelines document with respect to content
  • Author Reader Manuals to support the reader training process based on imaging charter, analysis eCRF and visualization software being used
  • Author final Study Reports if applicable
  • Develop imaging document templates as required by operational leadership to create efficiencies and development of standard look and feel across documents
  • Develop a standard library of reusable text to create efficiencies in document authoring
  • Author Standard Operating Procedures and Work Instruction Documents for Medical Writing group as necessary
  • Coordinate sign-off of document deliverables according to appropriate SOPs\WIDs, including distributing drafts, chairing round table meetings, and incorporating revisions
  • Perform quality control review such as copy editing, content editing, and number checking for other writers as necessary
  • Perform literature searches/reviews and research current guidelines as necessary to gather background information and training for development of documents
  • Attend internal technical team and client team meetings as required
  • Serve as Medical Writing representative on assigned Project teams
  • Regularly communicate project related issues with Medical and Scientific teams and the project team, as appropriate
  • Provide leadership, delegation of responsibilities and tasks to team members
  • Monitor workload to ensure direct reports can reasonably manage assigned task to meet project timelines
  • Manage performance of direct reports and conduct performance reviews
  • Participate in recruitment/interview process for new hires within the medical writing team

Qualifications:

  • Bachelor’s degree in Life Sciences/Health Related Sciences or equivalent
  • Medical/technical writing experience of at least 5 years in a clinical research setting
  • Previous line management experience
  • Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines
  • Able to work independently
  • Attention to detail and ability to multitask
  • Strong written and oral communications skills, as well as excellent interpersonal and negotiation skills
  • Knowledge of resource management and productivity metric management
  • Strong word processing skills including familiarity with MS Office production for documentation and presentation development

Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.