Senior Clinical Research Associate (m/f/d)

Job Description

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. 

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

We are continually striving to improve the understanding of health care within the local community. Our site in 1100 Vienna (ICON Tower) is a strategic location for the distribution of our high quality and innovative health care products, as well as digitally integrated solutions for our patients and clients. To ensure sustainable company growth, we continually aim to offer attractive career opportunities for more than 170 employees at our Vienna site.

Senior Clinical Research Associate (m/f/d)

                

Responsibilities

• Developing strong site relationships and ensures continuity of site relationships through all phases of the trial
• Performing clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents
• Conducting site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner
• Collecting, reviewing, and monitoring required regulatory documentation for study start-up, study maintenance and study close-out
• Communicating with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance
• Identifying, assessing and resolving site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed
• Contributing strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required

Qualifications

• B.A./Master`s degree required with strong emphasis in science and/or biology
• Proven CRA experience
• Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines
• Demonstrated ability to mentor
• Hands on knowledge of Good Documentation Practices
• Proven Skills in Site Management including independent management of site performance and patient recruitment
• Demonstrated high level of monitoring skill with independent professional judgment
• Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices
• Experience with conducting site motivational visit designed to boost site enrollment.
• Capable of mentoring junior CRAs on process/study requirements and is able to perform co-monitoring visits where appropriate
• Excellent communication skills in German and English (verbal and written)
• Willingess to travel up to 75% within Austria

We offer an attractive salary, outstanding social benefits and an exciting work environment with varied tasks in an international environment. The minimum annual salary for this position is EUR 59.200,- and varies according to the qualifications and experience of the successful candidate. We are looking forward to receiving your application.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

75%

Flexible Work Arrangements:

Remote

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

07/4/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.