Trial Oversight Lead/Manager
Posted May 3, 2022
Capital Region of Denmark
TFS HealthScience is excited to be expanding our Strategic Resourcing Solution (SRS) team and we are looking for an experienced, highly motivated Trial Oversight Lead/Manager who shares our vision of providing clinical research excellence. Our 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 organisation. Together we make a difference.
TFS HealthScience is looking for a Trial Oversight Lead/Manager to be working fully outsourced to one of our innovative Biotech clients (hybrid*) in Copenhagen, Denmark or Utrecht, Netherlands.
The Trial Oversight Lead/Manager will be will be responsible for the planning, conducting, and coordination of trial oversight activities together with internal and external stakeholders to ensure quality and integrity of the data. They will work closely together with the Clinical Trial Managers with the oversight activities across clinical trials.
- Develop the Sponsor oversight strategy together with the trial team
- Plan and perform oversight visits and booster/site oversight visits
- Accountable for development of trial oversight plan and ensure regular review of the trial team’s oversight activities
- Feasibility review
- Support Regulatory Green Light activities
- Drive eTMF spot-check for the trial team and in collaboration with the CTM and CTA
- Oversight of CRO training records, monitoring report review etc.
- Attend and coordinate CRA training activities with CRO
- Support during inspections and audits
- Minimum 2 years monitoring and/or co-monitoring experience of Phase I clinical trials
- 2-3 years’ experience as Clinical Trial Manager or Lead CRA within CRO and/or pharmaceutical company
- Extensive knowledge of working with trial oversight activities is required
- Structured and process oriented
- Quality mindset and able to prioritize your work in a fast paced and changing environment
- You have good interpersonal and communication skills during interactions with investigators and other external and internal stakeholders
- You are able to work independently as well as within global teams
- You are result- and goal-oriented and committed to contributing to the overall success of the company
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. Denmark benefits include:
- Competitive salary & benefits package
- Excellent career progression opportunities
- Great corporate culture and work life balance
- Health Insurance
- Occupational Work Injury Insurance
- Corporate pension plan
- Global General Liability Insurance
- Global Travel Insurance
- Flexible working schedule* 3 days in office, 2 days working from home