16 Oct
United BioSource
Great Britain
Job description
UBC are a leading provider of pharmaceutical support services, partnering with life science companies to demonstrate value, ensure safe use and accelerate patient access to innovative medical products.
Our services range from supporting the largest brands in the industry, to providing fully outsourced functional services, to the most recently approved genetic therapies in orphan populations.
The work we do positively impacts patients’ lives all over the world.
We are currently looking for a Sr Project Associate to join our ever growing EDS team!
Brief Description :
Working independently and reliably showing a high level of ownership,
also analytically minded with a strong focus on detail and committed to quality deliverables the Sr.
Project Associate (Sr. PA) provides administrative, operational and technical support to Project Manager (PM), Project Director (PD), and team members of assigned projects during any and all phases of the project.
The Sr. PA :
- Performs tasks as required under the direction of PM / PD / designee based on study requirements
- Prioritizes workload / schedule to meet project needs
- Supports the PM / PD in facilitating the project planning and decision-making processes
Project Administration & eSystems
Responsible for electronic administrative set-up of projects including Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF), project portals, study specific mailboxes, etc.
and the ongoing maintenance
- Act as Administrative owner and Subject Matter Expert (SME) within the Project Delivery department and project team for applicable e-systems
- Set-up and manage Project Team List
- Manage access to project specific e-systems for new / departing team members
- Conduct quarterly user access reconciliation.
Project Documents
- Support with the preparation of project documents i.e. project-specific logs, newsletters, draft study manuals and other study-related materials
- Prepare draft project plans (i.e. TMF Plan, Training Plan, Communication Plan)
- Manage the translation process for study specific documents, serving as the main point of contact with the translation vendor.
- Generate and update weekly / monthly project specific metrics, tracking, and reports
- Support PM / PD in reviewing project specific metrics, tracking, and reports for follow-up actions and trends
- Assists in maintenance, quality control, distribution, and archiving of project documents and reports
- Responsible for project Trial Master File (TMF) preparation, maintenance, and archiving
- Generate TMF Reports to monitor completeness, timeliness and quality
- Ensure TMF QC activities are performed, per project TMF Plan.
- Obtains, tracks, and maintains general project supplies and study materials
- Coordinates large and small mailings, e.g., supply shipments, courier shipments, etc.
Project Training & Compliance
- Prepare and maintain project specific training matrix
- Assign project related training to Project Team within the electronic Document Learning Management System
- Generate monthly Training Compliance reports and follow-up with Project Team Attend / complete project specific training as required
- Support PD / PM in preparation for all project audits
- Perform project management related quality checks in co-operation with PM / PD
Project Communication
- Schedule project team and client meetings
- Prepare and distribute draft meeting agendas and minutes for project team review.
- Distribute final meeting minutes to the project team and update Actions and Decisions in the Project Management Log.
- Coordinate the active follow-up of open actions and issues.
- Facilitates communication among team members
- Support PM / PD to manage 3rd party vendors (answers queries, provide study updates, etc.)
- Communicate with the client on specific items as directed by the PM / PD
Financial
- Support and collaborate on end-to-end management of investigative site, supplier, vendor payments for assigned projects,
in accordance with SOPs, project scope, and set timelines.
- Support set up and update new site / vendor purchase orders in applicable systems.
- Work alongside delegated team members (operations finance associate) to ensure CTMS payment module (CCT), Subject Visit Design and Funds are set-up for projects and sites.
- Support resolution of any discrepancies or issues related to invoices and payments.
- Contribute to project plans outlining payment strategy.
- Support PM / PD with financial activities related to the management of 3rd party vendors (invoice tracking, out-of-scope activity)
Other
- Complete routine administrative tasks in a timely manner (e.g. timesheets, expenses)
- Other duties as assigned by UBC Senior Leadership
Desired Skills and Qualifications :
- Minimum a Bachelor’s degree or equivalent in a science related field, with an advanced degree desirable, or sufficient, relevant job experience, or another relevant education
- Ideally 2+ years of Healthcare / Contract Research Organization (CRO) / / Pharmaceutical research / Project Management experience
- Excellent interpersonal, verbal and written communication skills
- Excellent organisational and time management skills
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload
- Analytical mind with high attention to detail
- Ability to work well and lead a team, as well as working independently
- Ability to successfully work in a ( virtual’) team environment
- Excellent work commitment and client-focused attitude
- Proficient in use of web based IT systems (e.g. TMF, CTMS, electronic Case Report Forms) and Microsoft (MS) Excel, MS PowerPoint, MS Project and MS Word
- Good knowledge of medical / scientific terminology and knowledge of ICH-GCP guidelines
- Proficient in local language (oral and written) and profound working knowledge of the English language (oral and written)
- Willingness to travel
UBC are a leading provider of pharmaceutical support services, partnering with life science companies to demonstrate value, ensure safe use and accelerate patient access to innovative medical products.
Our services range from supporting the largest brands in the industry, to providing fully outsourced functional services,
to the most recently approved genetic therapies in orphan populations.
The work we do positively impacts patients’ lives all over the world.
LI-AP1
LI-Remote
▶️ Sr Project Associate - Europe
🖊️ United BioSource
📍 Great Britain