Location: Any of the Company's offices in Europe (or remote) We are open to receiving applications no matter your current location as the position can be based in any of the Company's offices in Europe.
Who are we?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 26 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 Senior Data Managerto join ourData Managementteamand 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 changing every dayWorking with a highly experienced team of the clinical research professionalsInternational projects andprofessional growthPerformance bonusReferral bonusTraining opportunitiesWork from homeFlexible work hours Who are we looking for? Qualifications andExperienceBS or higher degree in a biomedical or technical discipline (ex. Biology, Biochemistry, Biostatistics, Mathematics, Informatics, or EngineryAt minimum 5 years of previous experience in similar positionsFamiliar with the life science market in generalExperience in pharmaceutical development processesExcellent written and oral English communication skillsAbility to define problems, collect data, establish facts, and draw valid conclusionsAbility to communicate effectively with appropriate internal and external contactsAbility to work on multiple projects and manage project timelinesGood organizational and time management skills and initiativeGood communication and presentation skillsComputer literacy YourresponsibilitiesCreate key data management documents including but not exclusive to:Case Report FormData Management PlanData Management ReportData Validation PlanSupport all data cleaning activities for assigned projectsWrite specifications for the set-up and modification of electronic data capture systems and other clinical databasesPerform verification and User Acceptance Testing of electronic data capture systems and other clinical databasesCreate and review CRF and eCRF completion guidelines, EDC system manuals and access instructionsDefine, write and validate Manual and Automatic edit checks for clinical data cleaningSpecify and review patient listings/tables for clinical data cleaningSet-up processes for reconciliation and perform reconciliation of data from external sources (e.g. Serious Adverse Events, IVRS, Central Laboratory) in collaboration with Safety internal and external departmentsLiaise with Data Management and Biostatistics Managers at regular intervals to discuss progress and any issues outstandingLiaise and collaborate with corresponding teams in other departments working on the same projectTrain other project team members to make full and correct use of the company Data Capture systems, when used, for the collection of clinical dataProduce information/reports directly from the clinical database or via the appropriate procedure to request a new report from the appropriate department or vendorLiaise with personnel at the sponsor company, or their designates, with Central Event Adjudication Committees, Data Safety Monitoring Committees, or any other third parties involved in data management activitiesDevelop and maintain relevant report metrics to share with the overall study team and upper managementSupport other departments with additional ad-hoc tasks such as preparation of newsletter, CRA training, etc.Apply company standards, and actively participating in improvements towards harmonization and standardization across projectsMaintain and expand the knowledge base in the area of expertise. To attend courses to develop and keep skills and knowledge current. To comply with continuing education requirementsBy 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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