Senior Clinical Research Associate

The businesses of Merck KGaA, Darmstadt, Germany•Billerica, MA

About The Position

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. EMD is building a scalable monitoring organization designed for quality, consistency, and operational excellence. The Senior Clinical Research Associate (Sr. CRA) will play a pivotal role in being a foundational member to the US clinical monitoring team. This position is ideal for an experienced individual for the US to perform primary monitoring, while assisting to build the future operational infrastructure. If you thrive in roles where you can design processes, uplift monitoring excellence, and shape the foundation for a future high-performing clinical monitoring team, this role offers a rare opportunity to lead that transformation.

Requirements

Strong experience (6+ years) in clinical research and site monitoring from start to end, preferably as a CRA in pharmaceutical, biotech, or CRO
Experience in clinical operations – ideally across Phases (I-IV) Oncology and/or Neurology and/or Immunology therapeutic area experience desired
Strong knowledge of clinical development (principles and concepts as well as regulatory requirements, Good Clinical Practice (GCP) and (ICH) guidelines, and applicable regional/local regulations)
Degree in Life Sciences (e.g., Pharmacy, Medicine, Biology, Nursing) or related field required.
Clinical Research Associate/ Clinical Research certification preferred.
Problem-solving and issue-resolution mindset.
Ability to work both independently and as part of cross-functional teams.
Solid understanding of ICH-GCP, EMA/FDA and local regulatory requirements.
Strong organizational and time-management skills, with ability to manage multiple sites/studies in parallel.
High attention to detail and quality mindset.
Excellent verbal and written communication skills in Local language and fluency in English (oral and written)
Proficiency in MS Office and clinical trial systems (CTMS, EDC, eTMF).

Responsibilities

Contribute to building a high-performing, scalable U.S. monitoring organization aligned with global standards.
Influence the long-term design of the U.S. insourced clinical monitoring model including providing insights to US training, templates and processes.
Individually support Clinical Monitoring activities across protocols, sites and therapeutic areas including identification and evaluation of potential investigative sites; participation in and/or conduct pre-study qualification visits including;
Prepare and conduct site initiation visits (SIVs), train site staff on the protocol, eCRF, safety reporting, and study procedures.
Plan, conduct, and document routine monitoring visits (on-site and remote) and close-out visits according to the monitoring plan.
Perform source data verification (SDV) to ensure accuracy, completeness, and reliability of data entered in the eCRF.
Ensure Data Monitoring oversight. Verify the integrity of data and adherence to study protocols and compliance with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements.
Ensure proper reporting and documentation of adverse events (AEs), serious adverse events (SAEs), and protocol deviations.
Track site performance (recruitment, data entry, query resolution) and implement corrective actions as needed.
Identify and resolve issues related to study conduct, including data discrepancies and protocol deviations.
Review essential documents in the Investigator Site File (ISF) and Trial Master File (TMF) for completeness and currency.
Ensure site inspection readiness. Support sites during audits and regulatory inspections, including preparation and follow-up of findings.
Maintain effective communication with investigators, site staff, and internal teams to facilitate smooth trial operations, including creation and distribution of communication materials.