2 External Data Jobs

We're looking for an experienced professional to join our team in Hyderabad, accountable for the setup and maintenance of External Data Streams within assigned clinical trials. You'll ensure these streams adhere to best practices and defined guidelines, contributing to the integrity and efficiency of our clinical data. Key Responsibilities Accountable for the setup and maintenance of External Data Streams within assigned trial(s) according to best practices and defined guidelines. External Data Streams include, but are not limited to, ePRO, eSource, EHR, Real World data , and traditional and novel clinical data streams (e.g., Labs, ECG, Biomarkers, PK/PD, PGx, IVRS). Your activities and deliverables will include, but are not limited to: Development of trial-specific data transfer agreements and specifications . Verification of data transfers . Setup of automated data ingestion into the clinical data repository. Principal Relationships Reports to : A people manager position within the functional area (e.g., Data Acquisition Leader). Functional Contacts within IDAR (Internal) : Leaders and/or leads in Data Management and Central Monitoring, Clinical and Statistical Programming, Clinical Data Standards, Regulatory Medical Writing, IDAR Therapeutic Area Lead, and system support organizations. Functional Contacts within JJ Innovative Medicine (as collaborator or peer) : Global Program Leaders, Global Trial Leaders, Biostatisticians, Clinical Teams, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human Resources, and Project Coordinators. External Contacts : External partners and suppliers, CRO management and vendor liaisons, industry peers, and working groups. Education and Experience Requirements Required Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Clinical Data Management, Health, or Computer Sciences. Advanced degrees (e.g., Master, PhD) are preferred. Approximately 5+ years of experience in the Pharmaceutical, CRO, or Biotech industry or a related field. Proven knowledge of data management practices (including tools and processes). Proven knowledge of regulatory guidelines (e.g., ICH-GCP) and standards (e.g., CDASH, SDTM). Intermediate project and risk management skills with an established track record of delivering successful outcomes. Established track record collaborating with multi-functional teams in a matrix environment and partnering with/managing stakeholders, customers, and vendors. Strong communication, leadership, influencing, and decision-making skills. Strong written and verbal communication skills (in English). Demonstrated technical expertise developing and maintaining External Data Streams (e.g., Labs, ECG, Biomarkers, PK/PD, PGx, IVRS) and associated components (e.g., Data Transfer Agreements, Specifications, transfer file verification, data ingestion set-up). Preferred Innovative thinking for optimal design and execution of clinical development strategies. Ability to contribute to the development and implementation of business change or innovative ways of working. Experience working with data from EHR/EMR, Digital Health technologies, Real-World Data, or similar, eDC systems, eDC integration tools, and general data capture platforms .

Role & responsibilities: Act as primary study contact, subject matter expert (SME) and liaison for external data and local lab processing on assigned studies for internal and external stakeholders. Communicate to Clinical Data Manager, study team, and/or Manager, External Data problems involving local lab data point issues and validation issues. Communicate to vendors and client issues involving external data transfers, data point issues and validation issues. Perform QC of laboratory normal ranges prior to entry to ensure documents received are ICH/CGP compliant and accurate. Perform Lab Normal Range data entry and/or QC, meeting processing deliverables on time and with quality. Review study protocols and local lab and external data eCRF design in start-up, providing recommendations and insights into best approach for data aggregation and capture. Ensure clinical database supports data requirements and is in alignment with external vendor data. Position: Senior External Data Specialist Job Description Template TEMP-104 v1.0 Perform QC of external data test transfers for acceptance. Maintain data transfer agreement set-up logs, reconciliation logs and/or change logs. Perform QC of laboratory normal ranges prior to entry to ensure documents received are ICH/CGP compliant and accurate. Verify the normal ranges are properly linked to the patient results in the local lab data collection module of the database. Review external vendor data and/or local laboratory data listings via elluminate and issue queries or communicate data issues to internal and/or external team members. Review and provide input to DMP, IDROP and CCG to ensure local lab normal range and/or external data process for assigned study is accurately documented. Perform local lab and external vendor associated study start-up and build activities. Perform IST activities for local lab normal range population. Develop the local lab and external data exception listing specifications and QC the output for movement to production. Drive the set-up and implementation of external vendor data transfer agreements and specifications, working closely with the client, vendors, and functional teams. Provide study specific local lab and/or external vendor data driven metrics to Clinical Data Management, Client and/or Project Management. Report client and/or study level local lab and/or external vendor data driven units to Project Management for scope monitoring. Attend internal and external study team calls, as needed, for support of study specific local lab and external vendor data processes. Identify and recommend process improvements, working with functional team leads and management for developing, reviewing, and implementing processes and guidelines for external data and local lab data processing. Support management for reporting of external data and local lab KPIs and performance metrics Work closely with cross-functional teams on study reporting and data trending via clinical data analytics technologies for local laboratory and/or external vendor data to proactively identify and mitigate risks. Contribute to digital transformation in external data management, leveraging emerging technologies to streamline process, ensure compliance and stay at the forefront of industry advancements. Utilize technology including AI ML and advanced analytics to perform real time monitoring to proactively identify and address data discrepancies, ensuring accuracy, integrity, and quality of various external and local lab data. Facilitate external and local lab data cross-functional team training. Professional Skills & Experience 5+ years experience or an equivalent combination of education and experience to successfully perform the key responsibilities of the job. Ability to maintain confidentiality of data and information during interactions with staff at all levels. Understanding of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology Basic understanding of medical terminology Excellent team player and collaborator Ability to work independently and manage multiple projects Detail oriented, ability to multitask, with strong organizational skills. Strong communication skills. Knowledge of clinical data management processes and vendor data processing Familiarity with various 3rd party vendors and data transfers. Understands a variety of external data types and methodologies. Strong leadership and mentoring skills. Considerable experience within the CRO or pharmaceutical industry. Apply using the link below. https://grnh.se/q396oq2f7us