Location: Company's office in Spain (Barcelona) and remote. Who we are?Optimapharm is a leading, mid-sized, full-service CRO working across Europe and North America to deliver new therapies to improve and save patients' lives. Optimapharm's key priorities are our people and consistently exceeding our client's expectations.
With 27 strategically located offices, Optimapharm operates in 40+ countries, giving unrivaled access to Patients and Investigators in all countries in Europe and North America.
In-depth expertise and long-standing experience, combined with a flexible and collaborative approach, allow optimization of design and planning; through its strong track record of delivery excellence and committed and stable project teams, Optimapharm has secured a high level of repeat business over the years.
We are looking for a new member to join our Data Management team in Spain. Whether you are a seasoned data management professional or you have technical knowledge and are looking to break into data management, you might just be a perfect fit for us.
What do we offer?Working in a successful company that's growing and developing every dayWorking with a highly experienced team of the clinical research professionalsInternational projects and professional growthCompetitive salary and performance bonusPremium Health insuranceTraining opportunitiesWork from home (and allowance)Flexible work hoursWho are we looking for?Qualifications and ExperienceBS or higher degree in a bio-medical or technical discipline, such as Biology, Biochemistry, Medicine, Biostatistics, Mathematics, Bioinformatics or Enginery or relevant experience in the industryat least 3-4 years of experience in data management in Contract Research Organizations, pharmaceutical companies, biotech companies, or similar excellent technical knowledge and experience with JavaScript, C and Pythongood knowledge of GCP and ICH Guidelines good knowledge of the English language, spoken and written ability to communicate effectively with appropriate internal and external contacts ability to work on multiple projects and manage project timelinesgood organizational and time management skills and initiativegood communication and presentation skillsability to define problems, collect data, establish facts, and draw valid conclusionsYour responsibilitiesworking on ongoing clinical studies to assure results are consistent with expectations, and quality control procedures are followedparticipating in the creation and review of key data management documents including:CRF SpecificationsCase Report FormsData Transfer Agreements/SpecificationsData Management PlansData Cleaning PlanseCRF Completion Guidelines preparing reports, listings, resource allocation forecasts and otherStudy Setup writing specifications for the set-up and modification of electronic data capture systems and other clinical databasesworking with vendor System Administrators/Programmers to develop, test and validate all project specific programming (if required)performing verification and User Acceptance Testing of electronic data capture systems and other clinical databasesdefining, writing, and validating Manual and Automatic edit checks for clinical data cleaning Study Conduct and Closeout supporting all data cleaning activities for assigned projects specifying and reviewing patient listings/tables for clinical data cleaning performing reconciliation of data from external sources coordinating database locks, performing data review meetings in collaboration required project team member, and Sponsor Unblinded Data Management performing activities such as executing unblinded data exports from EDS and creating the IP inventory management setup with supervision
Medical Coding of Terms and Medications performing medical coding using industry standard dictionaries Quality and Administration applying company standards, and actively participating in improvements towards harmonization and standardization across projectsparticipating in the creation and maintenance of the Data Management eCRF library initiating and/or participating in the improvement, development, and review of Company's Controlled Documents participating as necessary in sponsor qualification, sponsor audits, regulatory authority inspections, and other third-party meetings. Ensure that any recommendations are discussed and that solutions are incorporated entering and updating data in relevant CTMS modules timely and accurately participating in Optimapharm resource planning activities, if requestedBy 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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