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Clinical Research Associate II/III - Germany

Optimapharm d.o.o.
Berlin

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Details zur Stelle

Vollzeit
50.000 € – 60.000 € pro Jahr
vor 20 Stunden

Leistungen

Flexible Arbeitszeiten
Empfehlungsprogramm

Qualifikationen

Nursing
Forschungserfahrung
Master
Kommunikationsfähigkeit
Verhandlungsgeschick

Vollständige Stellenbeschreibung

Location: Preferably in the northern part of Germany

Who we are?

Optimapharm is a mid-sized, global Contract Research Organisation (CRO) turning science into hope through agile, patient-focused clinical development. We specialise in Phase I–IV clinical studies, delivering Full-Service and Functional Service Provision (FSP) solutions that help sponsors move faster and execute with confidence.

With operations in 40+ countries and 2x the patient reach of the average mid-sized CRO, we enable accelerated regulatory pathways, faster study start-up, and access to diverse patient populations worldwide. At Optimapharm, you’ll contribute to meaningful clinical research while growing your career in a dynamic, people‑focused, global environment.

We’re looking for a new CRA (CRA II - III, depending on experience). Whether you’re building your expertise as a CRA I or ready to step into a higher CRA role, this is your chance to shape the future of clinical research - delivering excellence for our sponsors and meaningful impact for patients and families worldwide. This role sits within a defined CRA career path: CRA I CRA II CRA III Senior CRA.

What do we offer?

Working in a successful company that’s growing and developing every day
Being part of a clinical research team that transforms science into hope for patients
International projects and professional growth
Working with a highly experienced team of clinical research professionals
Performance bonus
Referral bonus
Flexible work hours
Shopping discounts
Employee engagement programs
Well-being initiatives
Training and development program

Who are we looking for?

Qualifications and Experience

University degree, preferably in medical or life sciences; nursing education or other relevant healthcare college degree
At least 2 - 3 years of independent clinical trial monitoring in a CRO/pharma
High level of knowledge of ICH GCP Guidelines, knowledge of regulatory requirements and a strong interest in clinical research
Fluent in local language and English, both written and verbal
Computer proficiency is mandatory
Ability to read, analyze, and interpret common scientific and technical journals
Excellent verbal and written communication skills
Very good interpersonal and negotiation skills
Ability to work independently, pro-active
Affinity to work effectively and efficiently in a matrix environment
A current, valid driver’s license

Your responsibilities

Perform routine site visits independently, including pre-study, initiation, interim monitoring and closeout visits
Manage assigned sites by regular contact with site personnel to ensure site compliance, adequate enrolment and understanding of study requirements
Independently perform CRF review; query generation and resolution against established data review guidelines or data management systems as applicable
Identifying and escalating potential risks and identifying retraining opportunities for site personnel
Preparation of corrective and preventive (CAPA) plans for issues identified during monitoring activities and pro-active follow of each, individual CAPA until timely resolution
Preparation of documents required for EC submissions and notifications, translation of study-related documents (where applicable), and other tasks as instructed by the supervisor
Independently negotiate study budgets with potential investigators/institutions and assist with the execution of site contracts as applicable
Administration of site payments in accordance with relevant project instructions

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

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

Compensation is competitive and final offers will reflect each candidate’s experience, skills, and qualifications.

Disclaimer: Unsolicited CVs sent to Optimapharm (Talent Acquisition Team, Hiring Managers or any other OPT employee) by recruitment agencies will not be considered for this role. Optimapharm follows a direct sourcing strategy and collaborates exclusively with selected recruitment partners when external support is required.

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