Clinical Research Associate - Germany (with sign-on bonus)

Optimapharm; Frankfurt; Vor Ort; EUR 52.000 - 78.000; Vollzeit

Benefits dieser Stelle

Performance bonus

Referral bonus

Flexible work hours

Sign-on bonus

Training and development program

Well-being initiatives

Shopping discounts

Employee engagement programs

International projects

Career growth

Zusammenfassung

Optimapharm is seeking experienced Clinical Monitors to oversee site visits, data integrity and regulatory compliance across global trials. You will work within a matrix environment, coordinating with sites and sponsors to ensure compliant study conduct.

The role requires 2–3 years of CRO/pharma monitoring, strong ICH-GCP knowledge, excellent communication, and a proactive, independent work style. A valid driver’s license is preferred.

Qualifikationen

• University degree in medical or life sciences; nursing education or other relevant healthcare college degree
• Experience with independent clinical trial monitoring in CRO/pharma (2–3 years)
• Strong knowledge of ICH–GCP Guidelines and regulatory requirements
• Fluent in local language and English, both written and verbal

Aufgaben

• Perform routine site visits independently (pre-study, initiation, interim monitoring, close-out)
• Manage assigned sites with regular contact to ensure site compliance and enrolment
• Independently perform CRF review and data queries against guidelines
• Identify and escalate risks; identify retraining opportunities for site personnel
• Prepare CAPA plans for issues identified during monitoring and ensure timely resolution
• Prepare documents for EC submissions and translations as applicable
• Negotiate study budgets with investigators/institutions and assist with site contracts
• Administer site payments per project instructions

Kenntnisse

ICH-GCP knowledge

Language proficiency (local + English)

Verbal and written communication

Interpersonal and negotiation skills

Independent work

Matrix environment experience

Driver's license

Ability to read/interpret journals

Ausbildung

University degree in medical or life sciences

Tools

MS Office

Jobbeschreibung

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–10—IV clinical studies, delivering Full‑Service and Functional Service Provision (FSP) solutions that help sponsors move faster and execute with confidence. With operations in over 40 countries and two‑fold patient reach compared to 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.

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
• Sign‑on bonus

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 or 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, analyse and interpret common scientific and technical journals
• Excellent verbal and written communication skills
• Very good interpersonal and negotiation skills
• Ability to work independently, proactive
• Affinity to work effectively and efficiently in a matrix environment
• A current, valid driver’s licence

Your responsibilities

• Perform routine site visits independently, including pre‑study, initiation, interim monitoring and close‑out 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
• Identify and escalating potential risks and identify retraining opportunities for site personnel
• Prepare corrective and preventive (CAPA) plans for issues identified during monitoring activities and proactively follow up each, individual CAPA until timely resolution
• Prepare documents required for EC submissions and notifications, translate 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
• Administer site payments in accordance with relevant project instructions

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