TDM services provide for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials. These services lead the Study Management Team (SMT) and ensure regional/global clinical operations deliverables progress according to agreed upon timelines and milestones, including country & site feasibility and site selection, trial set-up, trial execution and trial closure and vendor set up activities as assigned by the Global Clinical Development Operations Trial Leader (GTL).
This service supports the GTL in leading related CRO, country, and site activities, including global vendors involved in site facing activities such as IVRS, Central Lab, ePRO, Imaging, Translation, Printing, Ancillary supplies and Meeting Planners.
Interface with stakeholders; internal and external to Global Clinical Development Operations (GCDO) functions, such as Study Responsible Physician, Global Data Manager, Trial Supply Manager, CRO staff, vendor staff and trial sites (if applicable). Work closely with the GCDO Trial Leader (GTL) and is member of the Trial Team, led by the GTL. Ensure inspection readiness through compliance with the clinical research protocol, company Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through close-out. Takes ownership for assigned responsibilities.
Demonstrated competency to act as a backup or first point of contact in absence of the GCDO Trial Leader. Advanced is given assignments that are more complex and/or have a greater potential impact on business results. May act as the lead over a team of TDMs across a project/program, on insourced and outsourced studies. Able to lead taskforces and provide innovative input. May contribute to process improvement and/or non-project work.
Essential Functions
• Participate in bid defense presentations in partnership with Business Development and may lead the presentation for smaller, less complex regional studies.
• May be responsible for delivery and management of smaller, less complex, regional studies.
• Develop integrated study management plans with the core project team.
• Accountable for the execution of clinical studies, or assigned portion of clinical studies, per contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
• Set objectives of the core project team and/or sub-team(s) according to agreed upon contract, strategy and approach, effectively communicate and assess performance.
• Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
• Monitor progress against contract and prepare/present project and/or sub-team information proactively to stakeholders internally and externally.
• Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts.
• Achieve project quality by identifying quality risks and issues, responding to issues raised by project team and/or sub-team members and planning/implementing appropriate corrective and preventative action plans.
• May serve as primary or backup project contact with customer and would then own the relationship with the project’s key customer contacts, as well as communicate/collaborate with IQVIA business development representatives, as necessary.;
• Build the cross-functional project team and lead their efforts; responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.;
• Ensure the financial success of the project.
• Forecast and identify opportunities to accelerate activities to bring revenue forward.
• Identify changes in scope and manage change control process as necessary.
• Identify lessons learned and implement best practices.
• May be assigned as the primary contact for vendors leading project vendor management and vendor management related activities as per project requirements.;
• Adopt corporate initiatives and changes and serve as a change advocate when necessary.
• Provide input to line managers of their project team members’ performance relative to project tasks.
• Support staff development and mentor less experienced project team members on assigned projects to support their professional development.;
Qualifications
• Bachelor's Degree Life sciences or related field Req
• 5 years of prior relevant experience including > 1 years project management experience or equivalent combination of education, training and experience. Req
• Advanced knowledge of job area, and broad knowledge of other related job areas, typically obtained through advanced education combined with experience. Req
• Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. 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.;
• Communication - Strong written and verbal communication skills including good command of English language. Strong presentation skills.
• Problem solving - Strong problem solving 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.
• Leadership - Ability to make decisions, bringing clarity to disparate information to inform actions and drive results.
• Organisation - Planning, time management and prioritization skills. Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others, experience planning activities in advance and taking account of possible changing circumstances.
• Prioritisation - Ability to handle conflicting priorities.
• Quality - Attention to detail and accuracy in work. Results-oriented approach to work towards delivery and output.
• Quality - 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 coworkers, managers and clients. Strong customer service skills.
• Cross-collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences.
• 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, Ownership).
*Please note This role is not eligible for UK visa sponsorship
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