Offer summary

Qualifications:

Bachelor's degree is advantageous., 5+ years of experience in CRO or Pharma industry., Good knowledge of ICH GCP and excellent communication skills in English., Ability to manage multiple tasks and work in a fast-paced environment..

Key responsibilities:

Maintain study trackers and generate weekly system reports.

Attend meetings, prepare minutes, and support project managers.

Manage system access and coordinate vendor materials for studies.

Guide teams in audit preparation and ensure compliance with KPIs.

Job description

📍Location: Home-based or at any of the company's offices throughout Europe that match your geographic location

🎯Who we are?

Optimapharm is a leading, mid-sized, full-service CRO aiming to deliver new therapies to improve and save patients’ lives.

Optimapharm’s key priorities are well-being of our people, consistent quality delivery to our clients and healthy, sustainable growth.

With 26 strategically located offices, Optimapharm operates in 40+ countries, providing most optimal access to Patients and Investigators globally. Established nearly 20 years ago, we leverage our experience, stable project teams and collaborative and flexible approach to secure a high level of repeat business, gain the trust of new customers and secure continued growth of the company.

We are currently looking for a Project Specialist to join our Trial Support team and support us in making a tangible difference to project sponsors and benefiting patients and their families all around the world.

🎁What do we offer?

Working in a successful company that’s growing and developing every day
Working with a highly experienced team of clinical research professionals
International projects and professional growth
Employee engagement programs
Well-being initiatives
Training and development program
Additional benefit package depending on the candidate's location (country)

🔎Who are we looking for?

💼 Qualifications And Experience

Bachelor's degree will be considered advantageous
5+ years of experience in similar roles in CRO or Pharma industry
Good knowledge of ICH GCP
Excellent verbal and written communication skills
Fluent in English, both written and verbal
Knowledge of another foreign language will be considered a plus (preferably German, but Spanish or French or Italian will also be beneficial)
Excellent interpersonal skills
Ability to work in a fast-paced environment
Ability to manage multiple tasks or multiple projects
Good presentation skills

📑Your Responsibilities

Study Coordination & Reporting – Maintain study trackers, manage logs, and generate weekly system reports (CTMS, eTMF, etc.).
Meetings & Compliance Support – Attend meetings, prepare minutes/action items, support PMs, and assist with audits and CAPAs.
Study Logistics & Administrative Tasks – Manage system access, coordinate vendor materials, oversee ISF divider distribution, support investigator payments, and handle project-specific trainings.
eTMF Management & Inspection Readiness – Set up studies in eTMF, maintain EDLs, upload/reconcile documents, track milestones, and ensure compliance with KPIs.
Audit & Team Oversight – Guide teams in audit prep, assist with eTMF-related queries, follow up on findings, lead eTMF discussions, and coordinate document submissions.

By joining our fast-growing and prosperous team, you will have a great opportunity for further personal growth and career development.

If you would be interested in joining the Optimapharm team, please send your CV in English and note that only shortlisted candidates that meet the requirements will be contacted for the further selection process.

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