TFS HealthScience is excited to be expanding our Strategic Resourcing Solutions (SRS) team and we are looking for an experienced, highly motivated Local/Regional Study Manager/Associate Director who shares our vision of providing clinical research excellence. Our Strategic Resourcing Solutions team is a highly experienced international group of professionals led by an industry expert.
We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.
Our cores values of Trust, Quality, Flexibility and Passion are what makes TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization. Together we make a difference.
TFS HealthScience is looking for a Regional Study Manager/Associate Director
to be home based in Poland
. This opportunity is permanent with career progression focus and will be one sponsor dedicated to one of our extraordinary pharmaceutical clients. We look forward to receiving your application!
Overall responsibility for managing projects in accordance with company policies, SOPs, regulatory requirements in addition to financial and contractual obligations.
Plan and pro-actively manage the study to ensure key milestones are achieved and studies are performed within budget, on schedule and in compliance with the appropriate - and quality standards.Key Responsibilities:
- Ensure that projects are delivered on-time, within scope and within budget and in compliance with applicable quality standards
- Manages the strategic aspects of projects, identify, analyze and minimize/mitigates any risk, including the implications of difference technical and operational choices.
- Communicates effectively with clients to successfully manage the relationship, identify needs and evaluate alternative business solutions and strategies.
- Develop and maintain Project Plans and timelines for their project and track progress
- Ensure all study team members -are adequately trained on project specific systems and procedures
- Implements, and maintains sound business practices
- Measure and evaluate project performance
- Manage the project budget, profitability and ensure invoicing is performed on time and in accordance with the scope of work
- Working with the Finance & Accounting team to analyze profitability, revenue, margins and utilization across their projects.
- Manage the resource allocation, on the project, in collaboration with respective line managers
- Facilitate internal and external communication
- Report and escalate to management as needed
- Establish and maintain relationship with third parties/vendors
- Manages high-level deliverables across the organization
- Participate in capability presentations/bid defenses, as needed.
- Continually defines ways to increase customer satisfaction and deepen client relationships.
- Contribute in review/develop procedures, guidelines, SOPs, metrics as needed
- Contribute to the continuous improvement of clinical operations through participation in working teams/ initiatives as needed
- Provide performance feedback of the team members to the corresponding manager
- Bachelor’s Degree, preferably in life science or RN diploma
- Previous Clinical Research Associate (CRA) experience
- 1+ year of relevant experience as Clinical trial manager, study manager or project manager
- Strong experience in any of the following therapeutics area Cardiovascular, Renal and Metabolism, Respiratory & Immunology studies
- Strong knowledge of clinical research regulations governing the conduct of the clinical trials and quality standards
- Understanding of project planning and metrics
- Ability to lead and manage staff
- Excellent oral and written communication skills in English/Polish
- Solid organizational skills and ability to prioritize
- Internal and external negotiation skills
What can we offer you?
A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS HealthScience is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients. Benefits include:
- Competitive salary and career progression plan
- The opportunity to be part of a friendly, supportive team and work with exciting technologies
- Home based flexibility
- Opportunity to work on a complex trial in challenging therapeutic area
- Additional 5 days paid vacation per year, in accordance with the Company’s vacation policy plus 2 additional days in December
- Private Health Coverage
- Global General Liability Insurance
- Global Travel Insurance