Manager, Site Start up
Takeda · Warsaw
Job Description
Objective / Purpose:
- As an experienced professional, you will work independently under general direction, using your expertise to solve complex problems related to clinical study start up.
- You will analyze diverse data and apply established methods, processes, and policies to determine appropriate solutions.
- As part of the role, you will also support and manage the day-to-day work of colleagues, including those working within an FSP model, through direction, guidance, knowledge sharing, and training.
Accountabilities:
- Establish, develop and deliver the Site Start Up Plan.
- Lead the Site Start Up team to implement the plan and drive delivery of Takeda and CRO-supported sites to Ready to Enroll status.
- Partner with Clinical Operations teams and TAU partners to improve site start up metrics, processes and overall study initiation performance.
- Provide guidance and oversight to the Site Start Up team across Clinical Programs, including protocol study start up, country and site selection, planning and modeling.
- Oversee the collection and analysis of clinical trial data to drive accurate, data-driven study start up forecasts, benchmarking, and scenario planning.
- Leverage industry tools and data sources to evaluate start up timelines, data quality and cycle times, supporting project teams with site initiation forecasting and decision-making.
- Ensure consistent standards are applied across project portfolios and contribute to continuous improvement of Site Start Up processes, methodologies and technologies.
- Develop site start up strategies aligned with therapeutic area needs.
- Agree site-level deliverables with the Site Start Up team, monitor performance and proactively address potential delays or non-performance.
- Resolve escalated site start up issues in partnership with the Study Manager.
- As part of the role, provide ongoing management, guidance and operational support to FSP colleagues, helping them navigate site start up activities, resolve operational issues and deliver against agreed expectations.
- Ensure site start up activities comply with Good Clinical Practice (GCP) and applicable regulatory requirements.
Experience & Competencies:
- 4 or more years of experience in Clinical Operations, Project Management, site start up and/or trial optimization, with evidence of increasing responsibility within a pharmaceutical company, CRO or relevant industry vendor.
- At least 2 years of direct responsibility in site activation and managing site start up processes for clinical research studies at a sponsor or CRO.
- Expertise in principles driving country/site start up and study start up strategies.
- Understanding and application of Good Clinical Practice (GCP) and relevant clinical trial requirements.
- Proficiency with software models and database structures.
- Ability to interpret and explain data and facilitate data-driven decision-making.
- Ability to manage complex activities with a high level of attention to detail.
- Ability to work independently and collaborate effectively with internal and external stakeholders.
- Ability to identify and resolve complex site start up issues and escalate risks where appropriate.
- Exposure to formal or informal people management, including providing direction, guidance and support to team members.
- Demonstrated ownership and accountability, with a proactive approach to driving activities through completion.
- Motivation to make an impact by improving ways of working and contributing to better study start up performance.
- European Site Start Up experience preferred.