SR CLINICAL PROJECT MANAGEMENT-ECOA OPERATIONS EXPERT - SPONSOR DEDICATED

Job Overview • Act as eCOA/ePRO and/or eConsent lead for the assigned trials providing expert input to the Clinical Trial Team (CTT) from protocol development, vendor selection to the execution of the respective eCOA component(s) and/or eConsent • Collaborate with internal and external business partners on the assessment of operational feasibility of Clinical Outcomes or Patient Reported Outcomes approaches.
• Ensure the management of PRO licensing and translations are performed in an efficient and effective manner.
• Operationalize PROs in trials, eg.
set-up ePRO systems, provide trainings for sites/investigators, liaise with CROs • Manage quality during trial implementation, i.
., monitor PRO completion and compliance rates • Liaise with CROs to monitor the PRO quality across the portfolio and track corrective actions on quality issues • Continuously strive for process optimization to ensure high-quality PRO data acquisition in our clinical trials • Minimize/reduce operational issues in study start-up phase leading to significant delays (related to the PRO licensing/translation, eCOA and eConsent system setup) • Serve as the point of escalation to study teams and facilitate solutions to the issues.
• Accountable for the eCOA/ePRO operations performance and quality metrics for the assigned trial(s)/program(s) identify trends, issues, and risks.
Work closely with CTT, vendor(s) and other internal and/or external business partners to ensure mitigation and contingency plans are defined and implemented.
• Identify and raise awareness of potential gaps/issues in eCOA/ePRO processes and contribute to facilitating solutions, working closely with relevant internal business partners and/or external partners, to ensure CAPA are defined and implemented.
Raise awareness of trends/ issues (within and/or across program) with key internal/external partners, department Leadership Team and/or senior management as appropriate • Responsible for the eCOA/ePRO/eConsent vendor(s) management; work closely with the vendor PMs to maintain the deliverables within the planned timeline, budget and the required quality standards • Contribute to ePRO/eCOA excellence by providing training to CTTs on ePRO/eCOA related aspects and lead and/or contribute to related process improvements and standardization of documents.
• Keep up to date with current practices in ePRO/eCOA activities, related innovations, technologies, vendors, regulatory changes and lead or contribute to continuous improvement intiatiatives.
• Act as eCOA/ePRO and/or eConsent lead for the assigned trials providing expert input to the Clinical Trial Team (CTT) from protocol development, vendor selection to the execution of the respective eCOA component(s) and/or eConsent • Collaborate with internal and external business partners on the assessment of operational feasibility of Clinical Outcomes or Patient Reported Outcomes approaches.
• Ensure the management of PRO licensing and translations are performed in an efficient and effective manner.
• Operationalize PROs in trials, eg.
set-up ePRO systems, provide trainings for sites/investigators, liaise with CROs • Manage quality during trial implementation, i.
., monitor PRO completion and compliance rates • Liaise with CROs to monitor the PRO quality across the portfolio and track corrective actions on quality issues • Continuously strive for process optimization to ensure high-quality PRO data acquisition in our clinical trials • Minimize/reduce operational issues in study start-up phase leading to significant delays (related to the PRO licensing/translation, eCOA and eConsent system setup) • Serve as the point of escalation to study teams and facilitate solutions to the issues.
• Accountable for the eCOA/ePRO operations performance and quality metrics for the assigned trial(s)/program(s) identify trends, issues, and risks.
Work closely with CTT, vendor(s) and other internal and/or external business partners to ensure mitigation and contingency plans are defined and implemented.
• Identify and raise awareness of potential gaps/issues in eCOA/ePRO processes and contribute to facilitating solutions, working closely with relevant internal business partners and/or external partners, to ensure CAPA are defined and implemented.
Raise awareness of trends/ issues (within and/or across program) with key internal/external partners, department Leadership Team and/or senior management as appropriate • Responsible for the eCOA/ePRO/eConsent vendor(s) management; work closely with the vendor PMs to maintain the deliverables within the planned timeline, budget and the required quality standards • Contribute to ePRO/eCOA excellence by providing training to CTTs on ePRO/eCOA related aspects and lead and/or contribute to related process improvements and standardization of documents.
• Keep up to date with current practices in ePRO/eCOA activities, related innovations, technologies, vendors, regulatory changes and lead or contribute to continuous improvement intiatiatives.
Qualifications • Bachelor's Degree Life sciences or related field Req • 10+ years experience in clinical research in a CRO and/or Pharmaceutical/Biotechnology Industry environment and 3+ years’ eCOA/ePRO/eConsent experience from start-up to closeout, translations, UAT scripts, systems set-up • Knowledge of clinical trials - Knowledge of clinical trial conduct and skill in applying applicable clinical research regulatory requirements i.
.
ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct.
Broad protocol knowledge, therapeutic knowledge desired.
• Good understanding of the competitive environment and how to communicate/demonstrate value through IQVIA solutions.
• Good knowledge on the purchasing of licenses to utilize questionnaire, translations and validation process • Good understanding of eCOA/ePRO system set-up process, operational set-up and data flow • Understanding of the overall clinical development paradigm, especially in clinical study operations and have global or regional experience.
• Project management and/or vendor management and oversight experience.
(PM certification -CPM, PMP- desirable) • Experience in multiple Therapeutic Areas, especially in oncology and immuno-oncology.
• Communication - Strong written and verbal communication skills including good command of English language Strong presentation skills.
Requires strong negotiation and customer management skills.
• Strong problem solving, negotiation, organisation, planning, time management, prioritazation and customer management skills • Leadership - Ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback, experience productively partnering cross functionally and with customers to advance work effectively and efficiently.
Ability to make decisions, bringing clarity to disparate information to inform actions and drive results.
• Quality - Attention to detail and accuracy in work.
Results-oriented approach to work delivery and output.
Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving.
• IT skills - Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint.
• Collaboration - Ability to establish and maintain effective working relationships with co-workers, managers and clients.
Excellent customer service skills and demonstrated ability to understand customer needs.
Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues.
Cross-collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences Good understanding of other IQVIA functions and their inter-relationship with Project Leadership.
• Finances - Good understanding of project financials including experience managing, contractual obligations and implications.
• IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, Innovation and Ownership).
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.
We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.
Learn more at https://jobs.
qvia.
om IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward.
Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities.
No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health.
Thank you for your interest in growing your career with us.