Clinical Trial Coordinator

Vacature

As a Clinical Trial Coordinator at AM-Pharma, you will be play a pivotal role in bringing to market this potential life-saving medical treatment. You will have the opportunity to work with a collaborative and successful team to support our Clinical Operations team with various activities. We pride ourselves on our amazing company culture, where we work as one team to achieve industry-leading results. The role reports into the VP of Clinical Operations.

The Project Clinical Trial Coordinator will be expected to take on the following tasks:
• Review and filing of non-essential documents (i.e. documents outside of regulatory packets)
• Management of REVIVAL email inbox (i.e. includes review, follow-up with email sender if necessary, filing, etc.)
• Distribute agenda and minutes for weekly Trial Team Meetings (Phase I Japanese trial as well as Phase III trial)
• Work extensively on filing system (Sharepoint) restructure and filing (previous trial documentation as well as current trial documentation)
• Coordinate and drive the review and collection of feedback from key stakeholders of all operationally related CRO project plans and trial related guides. Need to ensure that the plans/guides are updated appropriately and reviewed within outlined timelines
• Manage ad-hoc requests around clinical publications (i.e. reference checks, etc.)
• Oversight and review of the Phase III trial newsletter in conjunction with our CRO partner (i.e. request feedback from team members, provide feedback to CRO in a consolidated format)
• Review and maintenance of the Phase III Risk Log, Action Item Log and Decision Log for Trial Team Meetings as well as Project Team Meetings based on feedback/updates from team members.
• Preparation of internal communication tracker. Maintenance process still to be confirmed.
• Review and maintenance of the CRO contact list
• Complete ad-hoc clinical operations requests (i.e. due diligence requests, document requests, etc.)

Profiel

We expect the candidate to meet the following qualifications:
• Has proficient English language skills
• Has strong interpersonal skills and high attention for detail, with ability to handle multiple tasks efficiently and effectively
• Has good communication skills with ability to work in small team environment
• Brings previous project coordination/project assistant experience in clinical research
• Has the ability to analyze documents, project specific data and systems for accuracy and efficiency

Bedrijfsprofiel

Company Culture
The company culture of AM-Pharma is built on four important competences: Collaboration, Quality orientation, Accountability and Resilience. At AM-Pharma we work together in a constructive, collaborative and team-oriented way, towards achieving the company objectives without losing sight of our own objectives. We put the common interest of the company above our own individual interest. We set high standards regarding the quality of our materials, processes, documentation and collaborations, the staff are motivated to deliver excellence whilst also working to continually improve the quality of our work. We are fully accountable for the things that are in our power and control while working on the goals of the organization. We have an obligation to proactively report, explain and justify the things we do. We accept responsibility for our performance and we are transparent about the results of our work. Finally, we understand how to cope effectively with setbacks and obstacles and overcome hurdles on our way to reach our common goal. We stay committed to agreed objectives and company culture despite resistance while having the strength to adjust our plans when necessary. We are tolerant to stress and we deal effectively with criticism and resistance, building on our own strength.

Contact

Location
AM-Pharma is located in the World Trade Center Utrecht, located next to Utrecht Central train station.

Apply
Please send your CV and cover letter, stating the title of the position you are applying for, to hr@am-pharma.com.

More information: About us - AM Pharma

Locatie

Utrecht

Opdrachtgever

AM-Pharma

Publicatiedatum

25.06.2021

Publicatie eindigt

24.08.2021

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