Data Manager II (m/f/d) - Greece

Who are we

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

Optimapharm s key priorities are the 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.

As a Data Manager IIat Optimapharm you wont just be crunching data - youll be a key player in the success of clinical trials teaming up with experts across departments to keep everything clean accurate and on track. Were on the lookout for someone whos ready to bring their skills to a mission that matters - helping our sponsors succeed and making a real difference in the lives of patients and their families around the globe.

What do we offer

• Working in a successful company thats growing and developing every day
• Working with a highly experienced team of theclinical research professionals
• Internationalprojects andprofessional growth
• Performancebonus
• Referralbonus
• Private Health Care
• Work from home days
• Flexiblework hours
• Employee engagementprograms
• Well-being initiatives
• Training and development program

Who are we looking for

Qualifications andExperience

• BS or higher degree in a bio-medical or technical discipline for example Biology Biochemistry Medicine Biostatistics Mathematics Bioinformatics or Enginery or relevant experience in the industry
• 2-3years of previous experience in Data Management in Contract Research Organizations pharmaceutical companies biotech companies or similar
• Knowledge of GCP and ICH Guidelines
• Ability to define problems collect data establish facts and draw valid conclusions
• Strong analytic mindset and logical thinking capability
• Computer and arithmetic knowledge as well as skills to adapt to different computer systems
• Knowledge of at least one industry programming language (Python R SAS C JavaScript Java SQL VBA) would be considered as a plus
• Ability to communicate effectively with appropriate internal and external contacts
• Ability to work on multiple projects and to manage project timelines
• Good people-skills and team player
• Strong organizational and time management skills as well as initiative
• Good communication and presentation skills
• Excellent written and oral English communication skills

Yourresponsibilities

As a Data Manager at Optimapharm you will play a key role in the execution of clinical trials working closely with cross-functional teams to ensure the integrity and quality of clinical data. Your main responsibilities will include:

Core Activities

• Collaborate with internal and external stakeholders including Data Managers Statisticians Medical Writers Medical Monitors Project Managers and Sponsors to ensure data quality and project timelines.
• Contribute to the development and review of essential data management documentation (e.g. CRF specifications DMPs eCRF completion guidelines).
• Apply company standards and participate in process improvement initiatives.

Study Setup

• Develop and review specifications for EDC systems and clinical databases.
• Perform user acceptance testing (UAT) and validate edit checks (manual and automatic).
• Support setup and validation of randomization and unblinding procedures (with supervision).

Study Conduct & Closeout

• Execute and oversee data cleaning activities.
• Conduct reconciliation of external data sources (e.g. labs SAE data).
• Support database lock and coordinate with the project team and sponsor.

Unblinded Data Management

• With supervision assist with IP inventory setup and unblinded data exports within the EDC system (under supervision).
• With supervision monitor and escalate IP-related issues (e.g. temperature excursions) with appropriate departments.

Medical Coding

• Perform medical coding of terms and medications using industry-standard dictionaries (e.g. MedDRA WHO-DD).

Training & Quality

• Maintain up-to-date knowledge in clinical data management and relevant systems.
• Support training of team members in data management systems and best practices.
• Participate in SOP and process development audits inspections and CAPA follow-up.

Administrative Duties

• Perform administrative tasks ensure timely data entry in CTMS tools (LMS Timesheets) and support resource planning.
• Escalate unresolved or critical issues that may affect project delivery or regulatory compliance.

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.