Safety & PV Project Delivery Manager

Job Description

*Full time permanent role anywhere in EMEA. This is a non Line Manger role. Sr. Safety Project Manager.Come discover what our 25,000+ employees already know: work here matters everywhere. We re a growing and evolving biopharmaceutical industry leader, which means you ll have endless opportunities to work with experts around the world and build the career you ve dreamed of. As a part of the Syneos Health team, you ll help us deliver results for a rewarding reason we improve patients lives around the world. Because to us, a patient isn t just a number, they re our family, friends, and neighbors.Why Syneos Health #SyneosHealthLife means we re committed to our Total Self culture where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person s unique contributions make a difference. We believe our success is a direct result of the people who are driving it you We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives we re able to create a place where everyone feels like they belong.Job responsibilities Collaborates with Sponsor/Customer and major functional area leads (e.g. Project Management, Clinical Monitoring, SSU, Medical Writing, Data Management etc.) as the key liaison between the client and Syneos Health SPVG. Ensures all project deliverables meet the internal and external customers expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessments. Develops and maintains strategic relationships with customers in alignment with their assigned projects. May collaborate with business leads for business development, alliance management, contracts and proposals development, project management, and clinical management to achieve project goals. Ensures that individual project targets and client needs are met, services are provided with the highest quality standards, and policies and procedures are followed. Contributes to change initiatives across and within the SPVG department. Provides oversight of all project SPVG deliverables, which encompasses all activities throughout the duration of the project/program. Assumes accountability on SPVG deliverables including, but not limited to: Start-up safety activities (Kick-Off Meeting (KOM, Quick Start Camp (QSC)); Day to day operational management and execution of all project deliverables Financial performance and budget. Responsible for ensuring that SPVG services are within scope of work and escalating/raising Change Orders when necessary Develop detailed project/program specific Safety Management Plans and other project plans as applicable (e.g. communication plan, quality plan) Ensures adherence to and monitors project/program-specific key performance indicators (KPIs) Adequate project/program resourcing including annual leave and public holiday coverage Develops plans in accordance with Standard Operating Procedures and/or client-scoped process. Complies with all controlled document requirements and other requirements to ensure quality deliverables. Develops and manages integrated SPVG project/program delivery timelines and reports weekly progress including plans to address potential timing risks/gaps. Prepares and presents overall SPVG strategy and status at client meetings and communicates outcomes to project team. Reviews the project SPVG budget with the functional leads, project PM, and the SPVG Business Unit Controller against project milestones and budget to ensure project profitability. Takes corrective measures where necessary to keep project in line with budget and gross profit expectations. Accountable for ensuring that backlog for assigned projects is reviewed monthly and is an accurate reflection of work to be completed Uses professionally recognized tools for planning and management of scope, timeline, resources, and ensures that minimum hours are used for tasks. If out-of-scope work is requested, notifies the project PM and her/his SPVG manager and track out of scope until assigned to back log. Identifies best practices and initiates/participates in process improvement initiatives. May include providing assistance and guidance to Safety Program Delivery Lead colleagues Train/mentor key SPVG project team members on project/program specific tasks and a working knowledge of the project/program assigned Participates in audits/inspections and ensures inspection readiness at all times. Participates in quality investigations and implementation of corrective and preventative actions. Participates in new business development activities including participation at client presentations. Contributes to and reviews proposals, attends client sales-focused meetings, and provides information to support business development activities. Actively participate in team meetings. Designs presentations and delivers information in a way that allows the audience to understand the information and interact appropriately. Maintains understanding of and ensures compliance of SOPs, WIs, global drug/biologic/device regulations, GCP, ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study/program plans and the drug development process., *QualificationsWhat we re looking for Bachelor s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job. Minimum six to eight (6-8) years SPVG experience required preferably in a CRO industry. Safety database systems experience and knowledge of medical terminology required Experience with leading at least seven (7) large/complex projects/programs from award and into maintenance; at least two (2) of those projects/programs must have included multiple regions and/or multiple products. Excellent understanding of clinical trial process across Phases I-IV and/or post-marketing safety requirements, ICH GCP and regulations related to Safety and Pharmacovigilance. Project management experience in a fast-paced environment. Strong organizational skills with proven ability to handle multiple tasks. Excellent communication, presentation and interpersonal skills. Quality-driven in all managed activities. Strong negotiating skills. Strong problem-solving skills. Demonstrate an ability to provide quality feedback and guidance to peers. Contribute to a training within SPVG and update SOPs/WI. Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), TeamShare or other management/shared content/workspace) and internet. Strong leadership skills; ability to teach/mentor team members. Strong ability to analyze data and make appropriate decisions.Get to know Syneos Health We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.LI-JZ1

Keyskills :
customer relationsjavaproject managementdeliveryreporting