Assoc Clin Project Mgr

Associate Clinical Project Manager are an integral part of clinical trial delivery, liaising with clinical teams to improve patients lives by bringing new drugs to the market faster. The person is a member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies and practices. Clinical Project Management is focused on project delivery, productivity and quality resulting in strong financial performance and customer satisfaction. The Associate Project Lead support the efforts of CPM to drive operational excellence and strategic leadership with our customers. Person may run their own studies, as part of their development.

Essential Functions
Coordinate eTMF set-up together with TMF-specialist, Develop TMF plan and index, ensure eTMF is current, complete, correct and consistent. Collaborate with different teams. Manage and coordinate core file reviews and support audits as needed.
ICF- Request and review completed ICF checklist, Oversee development of required country/site ICFs, Review country master ICF, Document ICF revisions.
Manage Project Finances including monthly expenses, invoices, reconciliation and study budget tracking along with budget estimation
Organize and partner with CSM in managing internal project team. Prepare project status reports, presentation materials and meeting minutes. Establish and manage Study Dashboard.
Oversee posting of study information on public databases and Update information in ClinicalTrials.gov in consultation with sponsor
Coordinate development and review of draft protocol synopsis
Complete Study Set up in CTMS/applicable system, provide oversight, Assist with queries and clinical data flow, resolving discrepancies in the data and obtaining further details for incomplete information.
As per sponsor request, perform Data Privacy and Due Diligence prior to entering in any contract, Perform Anti-Bribery / Anti-Corruption due diligence. Ensure vendor management processes are followed (eg selection, PO)
Insurance- Follow required process to ensure insurance are placed and approved within set timelines
Review submission components to EC/Regulatory as per SOPs. Review and approve the final compiled submission package(s) provided to confirm that submission can proceed. Coordinate Sponsor review and document all decisions in TMF.
In case of questions raised by regulatory, coordinate Sponsor review and document all decisions in TMF.
In case of questions raised by IRB/IEC, coordinates sponsor and document all decisions in TMF.
Develop Study Training Matrix and distribute relevant study documents or training material to Study team. Review the Study Team Training Matrix and oversee compliance.
Oversee site start-up activities including documentation (eg CDA)
Confirm site agreement template and confirm budget according to Fair Market Value/SOPs
Review/Set up Coordinator Investigator Agreement(s). Coordinate review with sponsor legal and Data Privacy SME.
Confirm that green light checklist and site activation form is in place before site activation.

Provide input in to the development of integrated study management plans with the core project
team and/or sub-team.
Accountable for assigned portion of clinical studies as per the 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 project 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 internal stakeholders. Support the project leader to prepare/present project and/or sub-team information proactively to external stakeholders.
Achieve project quality by identifying quality risks and issues, responding to issues raised by project sub-team members and partner with project leader planning/implementing appropriate corrective and preventative action plans.
May serve as primary (for small projects) or back-up project contact with customer.
Forecast and identify opportunities to accelerate activities to bring revenue forward in partnership with the senior project leader.
Identify changes in scope and partner with project leader to 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

Qualifications
Associates Degree In life sciences or related field required Req Or
Bachelors Degree In life sciences or related field required Req
2 years clinical research experience. Req
Requires intermediate level knowledge of principles, theories, and concepts of a job area, 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.;
Communication - Strong written and verbal communication skills including good command of English language. Strong presentation skills.
Problem solving - Strong problem solving skills.
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.
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.
IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com