Senior Clinical Research Associate (Senior Site Manager)
Working with Johnson & Johnson can change everything. Including YOU.
Johnson & Johnson is recruiting a Senior Site Manager, located in Denmark.
The Site Managers (SM), commonly referred to as Clinical Research Associate (CRA) act as the primary point of contact for the study sites staff and work in close collaboration with the local project manager as well as the global study team and medical advisors.
- The SM has operational oversight and conduct all clinical site monitoring activities from site selection and study start-up, through database lock and close-out activities as described in GCO procedural documents.
- The SM is coordinating and leading the study site teams in order to deliver quality data and trial documents/records that are aligned with assigned protocol, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs) and regulatory requirements.
- The SM also train study site personnel on the protocol, study related data systems and applicable regulatory requirements.
- The SM actively support to process improvement; training and mentoring of other SMs.
- SM can work across Phase 1-3 studies in multiple therapeutic areas as needed to drive business needs.
We would love to hear from YOU, if you have:
Must haves: to be considered for this role, please ensure the minimum requirements are evident on your resume
- Bachelor’s degree in Life Sciences, Nursing or related scientific field is required
- A minimum of 2 years’ experience of monitoring in clinical trials.
- A validated understanding of the drug development process including ICH-GCP, Local laws and regulations.
- Strong IT knowledge as you will be working in different systems daily.
- Proficient Danish and English language, written and verbal.
- Valid driver license.
- Have a possibility to travel up to 50% of the time, with occasional overnight stay (may include Sweden)
- Experience from different Therapeutic Areas
- Experience from both Early and Late Development Clinical studies
- Excellent teammate with the ability to work independently.
- Ability to build positive relationships internally and externally.
- Open mind set-and contribute to improve processes in an efficient way.
- Listen and build an atmosphere of trust and mutual respect.
- Analytical and have a structured and organized working style.
- Strongly performance oriented with a passion of delivering high quality within agreed timelines.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .