Senior Clinical Research ociate
Senior Clinical Research ociate
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Job Description
Are you an experienced Clinical Research Associate looking to make a real impact At TFS HealthScience we invite you to be part of our specialized SRS/FSP team working alongside a global leader in the pharmaceutical and biotech sectors. As a Senior Clinical Research Associate youll play a key role in advancing clinical trials ensuring their quality integrity and success from initiation through to completion. Join us on this journey of transforming healthcare!
Key Responsibilities
- Submission & Amendment Support: Lead and assist with submissions and amendments to ethics committees ensuring the highest standards of accuracy.
- Regulatory Reporting: Oversee periodic safety and compliance reports to ethics committees guaranteeing all regulatory requirements are met.
- Preactivation & Site Initiation Visits (SIV): Support and contribute to site preactivation and participate in Site Initiation Visits to kickstart trial success.
- Monitoring & Site Management: Conduct both onsite and remote monitoring to maintain trial quality; build and maintain strong relationships with site teams.
- Documentation & Closeout: Manage the electronic Trial Master File (eTMF) and lead site closeout visits ensuring a smooth and compliant closure of the trial.
Qualifications
- Experience: A minimum of 5 years in clinical monitoring within CRO biotech or pharmaceutical environments.
- Education: Bachelors degree in Life Sciences Nursing or a related field.
- Regulatory Expertise: Indepth knowledge of ICHGCP guidelines and Swedish regulatory requirements.
- Technical Proficiency: Expertise in clinical trial management systems (CTMS) and eTMF platforms.
- Communication Skills: Strong verbal and written communication skills with the ability to build rapport with site staff and sponsor representatives.
What We Offer
We provide a competitive compensation package comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. Youll be joining a team that values collaboration innovation and making a difference in the lives of patients
A Bit More About Us
Our journey began over 27 years ago in Sweden in the city of Lund. As a fullservice global Contract Research Organization (CRO) we build solutiondriven teams working towards a healthier future. Bringing together over 800 professionals TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology Neuroscience Oncology and Ophthalmology.
Our core values of Trust Quality Passion Flexibility and Sustainability are our guiding light serving as the framework for decisionmaking at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments resulting in high employee engagement and satisfaction. By aligning on these fundamental values we cultivate a unified force geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.
Employment Type
Full Time
