Clinical Development Operations Assistant

Location
Cambridge, Massachusetts
Posted
Jun 22, 2022
Ref
R-11143
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time

Title:

Clinical Development Operations Assistant

Company:

Ipsen Bioscience, Inc.

Job Description:

To provide high quality, efficient and proactive support to the Clinical Development Operations members located in the French, Canadian, UK and/or US R&D sites, as applicable.

To rationalize the administrative organization of the team, be responsible for the administrative and financial management of contractors for CDO clinical operations.

To support Clinical Operations and local controlling for accurate management and tracking of cost center (budget, forecast, actuals…)

To coordinate and liaise with Clinical Development Operations in Europe and North America, and with other functions (e.g. Accounting, HR, IT, Procurement) for efficient conduct of the administrative tasks and facilitation of the communication across the departments.

Main responsibilities / job expectations

  • To arrange meetings (internal or external) as requested by Clinical Development Operations team leads, manage the booking of meeting rooms, the equipment required (e. g. videoconference…), the communication with attendees (to meet visitors and provide necessary support throughout their visit), the circulation of agendas, the organization for lunch, etc.
  • To arrange world-wide travels (flights and accommodation) if needed and support the team for the management of expense reports on a timely manner
  • To coordinate the registration of attendance at external conferences, seminars and training courses
  • To facilitate communication between the staff in the UK, in North America and in France
    • To be responsible for the administration of contractor mission: To raise the Commitment Requests and Purchase orders within K2 P2P tool and do the good receipts each month as requested by the finance controller, as well as manage invoices.
    • Enter in Iproject (Idid) the data of time spent on the studies by the Clinical Development operations contractors
  • As applicable, file the contractor contracts, work orders, CDA within the Legal repository tool in close collaboration with the Legal department (follow up of the
  • signature of the contracts/WO and archiving) (France only)
  • As requested, be the main contact with the Service providers to find new contractors
  • To provide support and onboarding of new comers working within the Clinical Development Operations team (to organize their arrival, set up the inductions, request the needed IT accesses, liaise with HR / IT…)
  • To Track in Collect all the transfers of value with HCPs and HCOs and ensure the reporting for the clinical trials are performed in a timely manner, liaising with the various Service Providers as requested
  • To maintain and update the SharePoint of the Global Clinical Development Operations TA in collaboration with the other CDO assistants and support the team in the use of the collaborative workspaces.
  • As requested, to produce the CDO newsletter monthly in collaboration with editors from GMA and R&D clinical operations
  • To help the timely collection, compilation, and consolidation of monthly clinical studies progress reports
  • To support Clinical Development Operations leads for tracking and monitoring compliance to time  tracking (IDID Tool) and compliance to SOP learning and trainings (GCP & others)
  • To track resources (FTEs) and internal costs in collaboration with the Clinical Development Operations leads and local finance representatives, to ensure accurate and timely quarterly financial reviews.
  • To be responsible for the archiving of the clinical trial documentation for the French (respectively the US) R&D site
  • To liaise and collaborate with the other assistants when necessary in case of common events and/or common activities (shared trackers/documents)
  • To attend training as appropriate to enable effective function within the scope of the position
  • To perform any other activity as may reasonably be requested from time to time, such as support to Clinical Trial Assistants: e.g. in the management of the clinical trial TMF, in the request of study country insurance
  • To complete all the above activities within the framework and in compliance with R&D SOPs, ethics and compliance guidelines and other documentation in force within the Ipsen Group

EHS responsibilities:

  • Comply with applicable EHS regulations and procedures.
  • Participate in the site's EHS performance by reporting risks, malfunctions or improvements
  • Participate in mandatory EHS training

Knowledge, abilities & experience

Education / Certifications:

  • Minimum of bachelor’s degree (US) or Administration/ Secretarial degree (FR)

Experience:

  • Prior experience supporting Research & Development in a corporate environment preferred.
  • Ideal: 3 years in a similar position within a Pharma company or CRO

Languages:

  • Fluent English

Key Technical Competencies Required

Communication (Level / Nature):

  • Excellent verbal and written communication skills.
  • Ability to work effectively within a multi-site, multi-national, multi-functional team.

Physical Position Requirements: Machines and/or Equipment Used

  • PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint, SharePoint)
  • Regularly required to operate standard office equipment (personal computer, photocopy machine, fax machine, etc.)
  • Ability to work on a computer up to 7 hours a day.
  • Regularly required to sit for long periods of time, and occasionally stand and walk.
  • Regularly required to use hands to operate computer and other office equipment.
  • Close vision required for computer usage.
  • Occasionally required to stoop, kneel, climb and lift up to 25 pounds.

In order to maintain a safe work environment, Ipsen requires all employees to be fully vaccinated against the Covid 19 virus at the time of employment.

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.