Associate Early Clinical Scientist-CLI002864
Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Clinical Trial Execution & Early Drug Development
The Early Clinical Scientist/ECS assists with the design, choreography, planning and execution of early phase clinical trials across the study team, under supervision by senior ECS staff and the Clinical Monitor.
In addition, the ECS:
- Works with internal functional area partners and external consultants to ensure study deliverables
- Ensures appropriate clinical safety assessment and risk management of compounds
- Conducts real-time medical oversight of ongoing trials with the Clinical Monitor and supervision by senior staff
- Reviews and summarizes clinical trial data with oversight by senior staff
- Partners with vendors on outsourced studies to ensure trials are completed on time with final reports
- Conducts on-site study monitoring, including site training & supervision of complex, novel endpoint/biomarker collection processes with guidance from senior staff
- Understands and applies ICH/GCP principles
- May represent Early Stage Development/ESD on cross functional teams charged with developing and/or improving clinical development procedures
- Works to apply best practices within the organization
- Follows departmental adaptation of new procedures
- Completes all required training for job role and for compliance with Merck policies
- Maintains up-to-date information on all projects within clinical trial management systems & planning databases
Technical Writing & Communications
- With oversight by senior staff, co-authors clinical and scientific sections of protocols, clinical investigator brochures, clinical study reports, Common Technical Document/CTD subsections, and regulatory agency update reports, as well as clinical development and experimental medicine plans, publications, and abstracts.
- Ensures that documents are completed in accordance with appropriate standards.
- Assists in developing site operations manuals for protocol procedures and sample collections.
- Manages trial and program projects (i.e. scope, timelines, issues, risks, etc.), including team activities (i.e. meetings, document/collaborative workspace management, etc.) .
- Familiar with early drug development processes, building knowledge and skills to effectively manage additional processes/procedures.
- Bachelor of Science
- 4-year degree (BS/BA) or ex-US equivalent from accredited university with 4-7 years relevant work experience*, MS with 2-5 years relevant work experience*
- *Relevant Work Experience includes (level of degree indicates expectation of experience in years as above unless otherwise noted):
- BS/BA degree with 4 years or MS with 2 years of direct experience in Phase I clinical development in industry (e.g., pharmaceutical/biotech company) or academia with understanding of operational execution of a Phase I trial
- BS/BA degree with 4 years or MS with 2 years of medical writing experience in Phase I (e.g., authoring/co-authoring Phase I clinical study protocols in human subjects/patients, clinical study reports, early results memos)
- At least 1 year experience with electronic data capture management systems and has performed medical data review (e.g., reviewing trends, conducting QC on clinical database, authoring queries, resolving data issues with clinical sit
- Experience with oversight/monitoring of Phase I clinical sites
- At least 1 year of experience with clinical trial management systems for tracking study milestones (e.g, CTMS, SPECTRUM, Siebel, etc)
- Working knowledge of GCP/ICH guidelines and familiarity with clinical trial and process audits
- At least 1 year experience with essential document management and trial master file (TMF) systems
- Experience with regulatory submissions (IRB/ERC) and understanding of requirements for regulatory submissions
- At least 1 year experience with vendor coordination and oversight
- Early Clinical Development (Phase I) trial experience
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
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Merck is an equal opportunity employer, M/F/D/V – proudly embracing diversity in all of its manifestations.
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Job: Clinical Research (Non-M.D.)
Job Title : Scientist
Primary Location: NA-US-PA-Upper Gwynedd
Other Locations: NA-US-NJ-Kenilworth, NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 2
Shift (if applicable): 1st
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