R21959 Temp Associate Mgr, Clinical Study

Pay Range: 50- 60

This is a 1 year contract/temp position. Candidates must be able to work on-site 2 days per week and 3 days from home. Locations are Tarrytown, NY/Armonk, NY OR Basking Ridge, NJ.

Remote work is not an option for this role.

Clinical Study Associate Manager (CSAM) role supports the Clinical Study Lead (CSL) by taking responsibility for areas of clinical trial delivery. This role applies to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs). The balance of direct execution versus oversight of CROs deliverables will vary accordingly. The individual will work 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 Regeneron Standard Operating Procedures (SOPs). Travel to study sites may be required to assist with monitoring clinical studies.

A typical day might include the following:

• Planning and running a clinical study in an assigned region(s) in alignment with the global study plans

• Contributing to risk assessment and helping to identify risk mitigation strategies

• Supporting feasibility assessment to select relevant regions and countries

• Supervising and giving input to the development of study specific documentation e.g. case report form (CRF), data management plan, monitoring plan, monitoring oversight plan, etc

• Providing regular status reports to team members as requested by the CSL

• Contributing to development and implementation of recruitment and retention strategies, and monitoring these accordingly

This role may be for you if:

• You are an excellent communicator with strong interpersonal skills, and capacity to establish relationships internally and externally

• You have a data driven approach to executing and problem solving

• You have a good attention to detail to deliver on specific study activities

• You are proactive and self-disciplined, and an ability to meet deadlines with an effective use of time

• You have budget awareness with the ability to get involved in various aspects of budget management

To be considered for this role you must have a Bachelor’s degree and 5+ years’ related pharmaceutical industry experience in Clinical Trial Management. Less experience with an advanced degree may be considered. We must have candidates who have vendor management experience, as well as experience in clinical trial operations including developing key study documents. We also require someone who has technical proficiency in trial management systems, Microsoft applications and TMF, as well as familiarity with medical terms, and a knowledge of Good Clinical Practice and regulatory guidelines. Up to 25% travel may be required.

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  This is a contract position at Regeneron with Magnit Global being the Employer.
• To do our best work we need different viewpoints. Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills. We strive to ensure that we maintain a positive and enriching work environment for all.