GSPV Project Lead, UK
Here at inVentiv Health Clinical we are currently recruiting for a GSPV Project Lead to be based in Maidenhead.
inVentiv Health: Work Here. Matters Everywhere.
As a member of our Global Safety and Pharmacovigilance team, working with colleagues across several countries you will be responsible for ensuring timely delivery of project required objectives and timelines within the scope of the client agreements for assigned GSPV projects.
* Collaborate with the Sponsor and internal colleagues as the key liaison between client and inVentiv Health GSPV for multiple projects
* Participate as the GSPV project lead in project launch through attendance of meetings (Hand- off and Kick-off)
* Develop detailed project specific Safety Monitoring Plans (SMP)
* Attend/Present at Investigator meetings where applicable
* Develop and maintain a working knowledge of assigned projects
* Interact with other company functions such as Clinical Project Managers, Site Monitors, Data Managers, Medical Monitors, and other colleagues to ensure the highest level of client satisfaction through successful execution of projects
* Participates in audits and resolves CAPAs
* Train/mentor key GPSV project team members on project specific tasks, an working knowledge of the projects assigned
* Delegate tasks and responsibilities to appropriately trained and capable individuals, and ensure tasks and responsibilities are completed accurately and on time
* Mentor less experienced staff in project management tasks
* Maintain a high level of expertise with client projects through participation in internal/external meetings as needed
* Participate in the preparation of documents for submission to regulatory authorities.
* Ensure submission of regulatory documents are completed on time
* Work closely with project team to coordinate project close-out
* Participate in the process of developing and/or reviewing SOP's
* Liaise with GSPV Program Delivery Management providing project status updates, needs or obstacles
* Contributes to projects with innovative ideas and recommendations and drives others to innovate.
* Ensures adherence to critical measurements (KPIs) and presents these as potential opportunities for ongoing process improvement.
* Any other duties as assigned by manager
The ideal candidate will need the following experience / skills to be considered:
* Bachelors Degree, preferably in a life science, nursing, pharmacy and proven safety/PV experience
* Proven experience in safety and PV processes/procedures or other clinical research area
* Proactive problem solver with excellent planning, coordination and organizational skills
* Demonstrated ability to manage multiple projects
* Ability to establish effective relationships with clients as well as team members
* Ability to prioritize successfully and work on multiple tasks
* Presentation skills required
* Excellent and demonstrated leadership skills
* Good knowledge of ICH guidelines and regulations relating to safety reporting
* Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
* Ability to travel as necessary (approximately 5%)
* Competitive remuneration package with excellent benefits
* Commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization
* Opportunity to work within a successful and rewarding environment.
To find out more about our company and search and apply for other open jobs please visit our website http://www.inVentivHealthclinical.com
inVentiv Health is a global professional services organization designed to help the biopharmaceutical industry accelerate the delivery of much-needed therapies to market. Our combined Clinical Research Organization (CRO) and Contract Commercial Organization (CCO) offer a differentiated suite of services, processes and integrated solutions that improve client performance. With more than 15,000 employees and the ability to support clients in more than 90 countries, our global scale and deep therapeutic expertise enable inVentiv to help clients successfully navigate an increasingly complex environment.