Syneos Health

Sr Project Manager (Sr Study Manager) - Poland, Sponsor-dedicated

Location
Home Based, POL
Salary
Competitive
Posted
24 May 2021
Closes
23 Jun 2021
Ref
21006189
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Senior Project Manager - Sr Study 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

Operational Study Management for 1 or more studies of moderate complexity generally with responsibility for all study management aspects of assigned studies:
  • Accountable for the development of realistic detailed study startup and monitoring plans
  • Accountable for conducting country level feasibility in collaboration with Global Clinical Trial Execution and CROs, reviewing Pre-trial Assessment outputs, approving sites, and assessing site activation plans
  • Leads study risk planning process in context of site and subject
  • Coordinates study/protocol training & investigator meetings
  • Develops and provides key inputs to Clinical Trial Budget (e.g., Per Subject Costs)
  • Accountable for the delivery of the study against approved plans
  • Leads inspection readiness activities related to study management and site readiness
  • May produce or review model Informed Consent Document (ICD) and study/country/site level ICD, as appropriate
  • May expand study design document into approved protocol template while incorporating input from other team members (e.g., Clinician, Clinical Pharmacology Lead, Supply Chain Lead, Statistician, Outcomes Research Representative, Clinical Assay Group, etc.)

Study Management Oversight:
  • Approves the Study Startup, Study Monitoring & protocol recruitment plans
  • Approves & oversees drug supply management - manages flow of drug supply to the sites & set up Interactive Voice Randomization System with Supply Chain Lead
  • Reviews consolidated Pre-trial assessment reports, feasibility outputs, etc.
  • May support study level submission readiness

Study Team Interface:
  • Leads and oversees all elements of study startup and monitoring functions both internally and at the CROs to ensure delivery & compliance with all applicable Standard Operating Procedures (SOPs) and Quality Standards, interfacing directly with CRO to determine Feasibility / Study Startup, Monitoring / Management & Site Contracting Groups
  • Works proactively with CRO and data management functions to ensure alignment on data flow and timely delivery
  • Shares and escalates plan deviations to Clinical Project Manager (and study team)
  • Provides ongoing assessment of subject enrollment / discontinuations to inform accurate forecasting for financial planning
  • Provides operational input into protocol design

Subject Matter Expertise:
  • The Study Manager will be the technical expert for study management systems and processes
  • The Study Manager will champion the implementation and use of harmonized, consistent processes and excellence in Study Management deliverables related to cost-effective, timely, and high-quality clinical trial data according to agreed global goals.
  • The Study Manager will be responsible for the technical oversight of the CRO to include but is not limited to: mentoring, standards, continuous improvement, issue escalation/resolution, inspection readiness/quality assurance, performance feedback, review of metrics.
  • The Study Manager partners with CRO Managers to proactively identify and resolve study operations staff performance issues
What we're looking for
  • Candidate with xtensive global clinical trial/study management experience
  • Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
  • BS/Nurse - minimum of 5 years relevant experience
  • MS/PhD - minimum of 3 years relevant experience
  • Demonstrated study management / leadership experience
  • Demonstrated oversight of CROs
  • Demonstrated experience in managing Per Subject Costs, vendor & ancillary, and monitoring costs projections & spend
  • Understands how to work with vendors to accomplish tasks
  • Ability to interpret study level data & translate and identify risks
  • Ability to proactively identify & mitigate risks around site level in study execution
  • Understands feasibility of protocol implementation
  • Country level cultural awareness and strong interpersonal skills
  • Keen problem-solving skills
  • Excellentcommunication skills, both written and verbal. Must be fluent in English.
  • Detail oriented & possesses technical expertise (e.g., spreadsheets, metrics & data flow management)

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 - MB1

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