Sr. Clinical Study Manager
Description
Cornerstone Search Group has been retained by a $1Bn+ (revenue) European pharmaceutical company focused in Oncology and CNS that is setting up their first hub in the USA in New York City. This newly-created, versatile, and hybrid Senior Clinical Study Manager (CSM) position will be leading clinical operations for a high-profile neuroscience asset (potential first-in-class) from Phase II through NDA, working directly with the MD leading the program. Our client is a well-established and financially stable company with a very positive culture. This is an exciting (and rare) opportunity to help establish a successful European company’s footprint in the US from scratch.
COMPENSATION: Highly competitive compensation
Location
New York City (hybrid)
Our client will consider candidates who prefer a hybrid work arrangement that would only require working on-site on a limited basis.
Features
(1) This company takes a lot of pride in its culture, reflecting its country’s heritage as having one of the world’s most positive cultures.
(2) You will work closely with the clinical leadership of this company on the asset as well as on establishing this company’s presence in the US.
(3) Our client has a portfolio of Oncology and CNS pipeline assets and a successful history of discovering and developing many Oncology and CNS marketed drugs.
(4) Our company is comfortable with a hybrid and flexible work arrangement.
Responsibilities
As a Senior Clinical Study Manager, you will be accountable for the operational oversight of clinical trials, starting with being the lead on a high-profile, potential first-in-class, neuroscience asset entering Phase II in multiple arms. The goal is for this Sr. CSM to lead this asset through Phase III and NDA. The scope includes trial start-up, conduct, and close-out activities as well as training and overseeing the CRO (which will be monitoring these trials) and other clinical service providers.
Desired Skills / Qualifications / Experience / Behaviors:
- BA/BS required. Master’s is a plus.
- 5+ years of relevant experience for a pharma or CRO. Experience with a biotech or smaller pharma is a plus.
- Seeking experience with developing trial plans including oversight plans, site monitoring plans, pharmacy and lab manuals, risk mitigation strategies, and trial budgets.
- Working knowledge of MS Project or similar project management tool.
- Experience within, or managing of, a CRO is a plus.
- CNS /Psychiatric / Pain experience and/or Immunology / Inflammation and/or Acute Care / Hospital and/or Oncology (their other major TA is Oncology) is a plus, but not required.
- Strong written and verbal communication skills.
- Seeking a proactive, self-motivated, and entrepreneurial individual who is transparent, flexible, builds trusting relationships, is highly collaborative, and values being part of and contributing to a company that is very culture-focused.
Contact
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