BrightOwl Loader Loading

Associate, Data Solutions, Clinical Pharmacology United Kingdom,  


Posted on : 20 April 2017

Project Description

AutoReqId 32844 Title Associate, Data Solutions, Clinical Pharmacology City Windlesham State / Province Surrey Country United Kingdom Position Location Local Company Overview Eli Lilly Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.We were founded in 1876 by Colonel Eli Lilly, a man committed to creating high-quality medicines that meet real needs. More than a century later, we are passionate about building on this precedent in our continued pursuit to make life better for individuals, communities, and the world around us.Our heritage and our values are the foundation of our promise to unite caring with discovery to make life better for people around the world.Our missionWe make medicines that help people live longer, healthier, more active lives.Our valuesIntegrity, excellence, respect for peopleOur visionWe will make a significant contribution to humanity by improving global health in the 21st century. Responsibilities 1. Technical Leadership (50%)Consults to ensure that data acquisition, database design, and observed dataset requirements are reflective of specific protocol objectivesProvides direction and expertise to study teams to secure adherence to Lilly standardsProvides input to ensure controls are in place to secure data integrity and patient privacy is maintainedProactively anticipates and prevents technical problems from impacting final data deliverables, mentors others on technical problem prevention and resolutionSupports project teams on achieving client satisfaction through delivery of quality data, on-time and on-budgetProactively provides technical guidance to study teams regarding data system processes and requirementsProvides expert review and guidance in the development of CRF/eCRF design specifications, database design specifications, validation specifications and report design.Ensures consistency of data collection across studies and programs, applying both Lilly standards and industry initiatives (e.g. CDISC) as necessaryHelps create scope scenarios and negotiates outcomes with study teams while taking into account the cost and value of scenariosUtilizes therapeutic knowledge and possess a deep understanding of the technology used to review data to ensure database deliverables are consistent and accurateEffectively applies knowledge of internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to data deliverables2. Submission Activities (25%)Coordinates delivery of submission package relative to data management deliverables (i.e., aCRFs, DDD, datasets, notable CRFs) for clinical pharmacology including timeline management and location/conversion of legacy trial data.Consults with biopharm coordinator for contracting submission activities with vendorMaintains suite of tools for document creation/review of submission deliverablesProvides ongoing solutions for publishing requirementsMaintains current knowledge of industry and regulatory standard requirements for submission activities, frequently liaisons with key cross functional partnersPartners with team members for regulatory responsesFacilitates the availability of data for submission activities3. Vendor Relationship (10%)Establish and define quality assurance oversight plans and metrics associated with outsourced servicesEnsures vendor performance for the program level i.e., flow of data, including across niche vendors and niche data sourcesWorks with internal partners to increase vendor/sponsor efficiencies and support collaborative relationships4. Process Improvement (10%)Continually seeks and implements means of improving processes to reduce cycle time and decrease work effortActively participates in shared learning within and outside of Clinical PharmacologyWorks with partners to increase vendor/partner efficienciesInterfaces with customers on solutions, requirements, continuous improvementCollaborates with peers to establish global data management competency models and assist with the development of training programs and ensure staff achievement of role competencies5. Asset Protection (5%)Understands the confidential nature of company information and takes necessary steps to ensure its protection. This includes understanding various aspects of Privacy as it relates to the data managed within function.Ensures that an appropriate confidentiality agreement has been executed before disclosing confidential company information to CROs or other outside partiesAccepts obligation to Lilly for compliance to the integrity of the company 32844BR Basic Requirements: Education and Experience Bachelor s degree or equivalent experienceMinimum of 3 years  experience in clinical data management and/or 5 years  experience in drug development in areas intersecting with clinical data management (e.g., clinical operations,statistics, information technology, health outcomes, etc.),Ability to work in ambiguous situations within the team to identify and resolve complex problemsDemonstrated extensive in-depth knowledge of data management processes and principles in the specialty and the ability to articulate: Data flow, structure and format of data, CRF Design, Clinical Data Base Development, Randomization, Data Acquisition, Data Movement, EDC, CRF Processing, Submission Assembly and Validation ProceduresClinical knowledge and an ability to liaise effectively with study team members (i.e. Data Sciences, Statistics, PK, Operations, Medical)Demonstrated ability to understand customer perspective and deliver solutions that meet expectationsAbility to work cooperatively with key internal and external stakeholders to ensure successStrong SDTM and therapeutic/scientific knowledgeVendor mgmt, Project mgmt, and virtual team environment experiencePreferred Skills:SCDM certificationStrong interpersonal and leadership skillsExcellent oral and written communication skillsFamiliarity with clinical data tools and technologiesTechnical knowledge to develop requirements and/or study/project deliverables (i.e. SAS,Oracle)Experience in forms design and layoutUnderstanding and experience in using data standardsKnowledge of medical terminologyProcess management expertiseOther information:Domestic and International travel may be required

Locations

Surrey United Kingdom

Find a Job Find Candidates

Most Recent Searches

Most Famous Searches

You might also like