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IMMEDIATE CLINICAL TRIALS ASSOCIATE MANAGER OPPORTUNITY WITH LEADING BIOPHARMA!!
This opportunity is with a multi-billion dollar company who is currently leading the industry with 10+ marketed drugs and a robust pipeline containing multiple trials in phases I-III. In addition, 100% of their drug candidates are invented and developed in house ! This company has great culture and is rapidly growing!
Summary: The Clinical Study Associate Manager role supports the Clinical Study Lead by taking responsibility for areas of clinical trial delivery. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct execution versus oversight of CROs deliverables will vary accordingly. The Clinical Study Associate Manager works with the study team internally and externally with vendors such as CROs in feasibility, planning, initiation, maintenance and closeout of clinical projects according to GCP, ICH, CFR and Standard Operating Procedures (SOPs). Travel to study sites may be required to assist with monitoring clinical studies.
Qualifications:
5+ years of experience in Clinical Research
1-2+ years of Trial Management experience (Pharma/CRO)
1-2+ years of Vendor/CRO Management experience
eTMF Experience (Experience maintaining the eTMF (file, upload, scan, QC all study documents such as 1572, financial disclosures, informed consents, CV’s, etc. as per company SOPs and FDA guidelines), including supporting periodic review of study files for accuracy and completeness.
Experience taking meeting minutes/preparing meeting agendas
Bachelors Degree minimum
Benefits:
Medical, Dental, Vision, 401K
Paid Time Off
Holiday Pay
Sick Leave
Remote Flexibility (hybrid 3X per week onsite)
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.