Associate Clinical Project Manager (mwd)
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Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Associate Project Leads 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 Associate Clinical Project Manager (m/d/w) 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. Associate Project Leads may run their own studies as part of their development.
Main Responsibilities
Work with IQVIA Clinical Operations team and other team members (DM Reg CMC etc.); ensure exhaustive feasibility reports; review site feasibility reports; support CTM in site selection; verify timely collection of essential documents; ensure all set-up activities are completed before site initiation as per oversight plan.
Ensure all clinical responsibility tasks in EDC system are completed on time without delaying trial start.
Support Clinical Operations in training CRAs on study-specific operations; participate in organizing monitor and investigator meetings with study team members (corporate affiliates CROs).
Assist CTM/study team in evaluating timelines and establishing milestones for assigned projects ensuring quality and timely delivery.
Assist in producing documents for clinical activity implementation monitoring and reporting (e.g. oversight plan monitoring metrics).
Validate final clinical study documents (study manual monitoring plan) prepared by Clinical CRO.
Review all/sample site visit reports per Oversight Monitoring Plan; ensure timely follow-up of issues raised by monitors.
Provide support and guidance to Internal CTAs if applicable.
Set up regular meetings with MSL to support Clinical Operations (site qualification recruitment) if applicable.
Participate in ongoing clinical study data reviews with study team members.
Ensure timelines for data collection (CRF/eCRF) and data clarifications/queries are met.
Ensure study samples/assessments flow per protocol between stakeholders (CROs vendors departments) from site to central facility/lab.
Participate in TMF quality check reviews regularly; ensure completion during study and final review before archiving.
Prepare/follow up on other study systems (IWRS/IMP forecasting/flow) as required.
Prepare study documents perform site visits before audits/inspections assist in audit follow-up and findings resolution.
Complete co-monitoring visits per monitoring plan.
Perform study-related functions to ensure execution of clinical studies aligns with GCP and other standards.
Qualifications
Bachelors Degree In life sciences or related field
2 years clinical research experience.
Requires intermediate level knowledge of principles theories and concepts of a job area typically obtained through advanced education combined with experience.
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.;
Strong written and verbal communication skills including very good command of English language.
Strong problem solving 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.
Ability to handle conflicting priorities.
Results-oriented approach to work towards delivery and output.
Ability to establish and maintain effective working relationships with coworkers managers and clients.
Ability to work across geographies displaying high awareness and understanding of cultural differences.
Good understanding of project financials.
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
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.
Required Experience:
IC
Key Skills
About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more
