(Associate) Clinical Project Manager Sponsor Dedicated (Fixed-term Contract for 6 months)
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Job Location:
Monthly Salary:
Posted on:
18 hours ago
Vacancies:
1 Vacancy
Job Summary
The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our clients project team in the execution of clinical trials. Joining the team provides the opportunity to manage phase II-III clinical research projects in different therapeutic areas and to cooperate closely with one of our key clients.
We currently offer the exciting opportunity to join the team as (Associate)Clinical Project Manager (full-time; 6-month FTC) in this role you will be accountable for the operational management of the component of clinical trials. Furthermore you will need to gain an oversight to assure achievement of trial recruitment commitment timelines budget and quality standards.
MAIN RESPONSIBILITIES
Manage the execution of clinical studies or assigned portion of Phase II - III clinical studies; including orchestration of local trial team and integration with other functions as necessary throughout planning conduct and closeout of trial.
Work within a complex GCP and regulatory environment and on global clinical trials with multidisciplinary international teams and with various internal and external stakeholders including suppliers and investigational sites.
Lead and support local trial team in France and investigative sites in timely preparation of required trial documents contracts and necessary approvals.
Ensure compliance with ICH-GCP and all other relevant regulatory regulations as well as accordance with client SOPs and values.
Assure highest ethical and professional standards patient safety and that local component of trial is planned conducted and reported in line with regulatory requirements.
Set up manage and review operating unit trial budget to ensure appropriate level of financial oversight and timely budget updates based on trial changes.
Develop and maintain relationships with investigational sites and support CRAs in site contacts.
In collaboration with Site Monitoring Lead and CRAs ensure:
o provision of appropriate trial oversight for the trials by monitoring compliance of trial sites and team to GCP local regulations customer SOPs and adherence to trial protocol.
o adequate trial supply distribution to sites.
o continuous and timely data entry and cleaning and on time Data Base Lock.
o collection of required documents with timely complete and compliant archiving of all relevant documents for the eTMF and CTR Appendices.
Identify risks and contingencies and partner with project leader in problem solving and resolution efforts.
Participate in and actively drive organizational quality and process improvement initiatives to commence future leading change.
REQUIRED KNOWLEDGE SKILLS AND EXPERIENCE
Masters or higher-level degree preferable in life science.
Long term experience in clinical research including at least 2 years of clinical trial management experience.
Knowledge of applicable clinical research regulatory requirements i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Understanding of project financials and effective vendor management.
Therapeutic area knowledge in any of the following would be an advantage: rare diseases intensive care cardiology bone metabolism disorders.
Effective communication skills fluent languages skills in French (at least C1 level) and very good command of English.
Familiar with Veeva as CTMS/ TMF.
High organizational and planning skills time management and prioritization skills while working on multiple projects.
Excellent leadership and collaboration skills and the ability to establish and maintain effective working relationships with coworkers managers and clients. Ability to influencing business partners in matrix structures.
Very good computer skills including working knowledge of Microsoft Word Excel and PowerPoint.
Strong problem solving skills.
Flexibility to business travel to Paris for client meetings.
Please note: Depending on the candidates experience and assessed seniority level this position may be offered as Associate Clinical Project Manager or Clinical Project Manager
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
- Bluebeam
- Construction Estimating
- Construction Experience
- ProCore
- Microsoft Outlook
- Prolog
- Construction Management
- Project Engineering
- Project Management
- Project Management Software
- Microsoft Project
- Budgeting
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
