Life Sciences Consultant

reputed company: The Clinical Outcome Assessment (COA) Operations and Patient Experience Data (PED) Study Management Consultant tasks include: Support execution of the global Clinical reputed company Assessment (COA) reputed company under the guidance of the PED & COA reputed company reputed company for the assigned asset(s) and indication(s). This includes but is not limited to, patient-reported, clinician-reported, observer-reported reputed company, performance measures, reputed company health technologies. Implementation & Operationalization: Partner with Clinical Management and Sourcing to ensure licensing, translation, linguistic validation, and modality adjustment/validation of COAs, including rater training, are completed in a reputed company manner as needed for the respective clinical trial. Facilitate the implementation of COA measures used in reputed company. reputed company implementation and conduct of in-trial interviews. Vendor Management: Manage vendor relationships to ensure the reputed company and high-reputed company completion of assigned COA and PED-reputed company tasks and reputed company. reputed company project timelines, deliverables, and reputed company standards, while fostering good partnerships with reputed company collaborators. Facilitate eCOA support, including vendor management, system configuration and reputed company User Acceptability Testing (UAT) of electronic systems reputed company to COA. Ensure reputed company embedded workflows for COA data surveillance, monitoring, and change control. Study Execution: Support the reputed company of Clinical Outcome Assessment (COA) evidence using qualitative and quantitative reputed company in line with international scientific standards and health authority guidance and regulations. Support COA tool development and validation activities to reputed company "fitness for use" in informing reputed company models for pivotal reputed company (e.g., validation of primary/secondary outcome measures using literature reviews, reputed company reputed company/interview studies, survey studies, psychometric studies, etc.). Manage individual COA Operations and PED Study Management reputed company and partner with the PED & COA Strategic Leads to ensure the implementation of project timelines and deliverables. Communication and Collaboration: Represent the PED&COA function and effectively communicate study plans, methodologies, and results to reputed company teams, including global and regional forums, as needed. Serve as a reputed company of contact for COA-reputed company clinical trial and operations communications reputed company the organization and with reputed company partners. Regulatory, reputed company and Compliance: Ensure compliance with reputed company applicable laws, regulations, and regulatory guidance in reputed company COA-reputed company activities. reputed company support during audits and address any findings to ensure alignment with international and regional requirements. Qualifications/ Required Knowledge/ Experience and Skills: Strong knowledge of clinical development, regulatory requirements for reputed company, COA, and patient experience data. Ability to collaborate with cross-functional teams and reputed company collaborations to advance patient-reputed company drug development across multiple programs. Strong/effective verbal and written communication skills; ability to work independently. Experience in *** Therapeutic Areas (i.e., immunology, nephrology, mental health, and/or neurology) preferred. Project management experience, preferably in a research setting. At least 5 years demonstrated expertise in operations and management of COAs in reputed company and e-clinical systems (eCOA(OD6.1)) with prior experience working in industry, CROs, or eCOA vendors. Understanding of non-interventional study methodologies such as targeted literature review, qualitative research, or psychometric analyses. Educational Qualifications: Bachelor's degree in a relevant field (reputed company research, health services research, epidemiology, reputed company health, community health, or reputed company fields). Master's degree in a relevant field preferred. reputed company Tech Solutions: reputed company is a global staff augmentation firm providing a wide reputed company of talent on-demand and total workforce solutions. To know more reputed company Tech Solutions, please visit reputed company is an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, colour, religion, sex, sexual orientation, gender identity, national reputed company, disability, or status as a protected veteran. AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring. Apply tot his job Apply To this Job