Sr. Clinical Study Manager - OTC, New Jersey, Major Pharma

Sr. Clinical Study Manager – OTC, New Jersey, Major Pharma

 

Profile: A very successful large global healthcare (pharmaceutical and consumer/OTC) company is looking for a full-time SR. CLINICAL STUDY MANAGER to join their team and manage domestic and global Rx-to-OTC and Consumer Healthcare studies. This is a fast-paced environment where you will be multi-tasking on multiple simultaneous projects. The responsibilities are wide-ranging because although this is a larger company, their clinical research department operates more like a fast-paced smaller company. You will responsible for developing protocols, to selecting and managing CROs, to being responsible for timelines, to creating and managing budgets, to writing final clinical study reports, to presenting to senior management, to working closely with marketing, etc. The company has outstanding benefits (including 4 weeks vacation plus closed during Xmas week) and is conveniently located in the heart of NJ’s pharmaceutical corridor.

 

Location: Located in the highly attractive Parsippany/Morristown metro area, accessible from Central NJ or Northern NJ via 287, from areas west via 80, from Hoboken or Jersey City (via 280 or 78), and it’s only 45 minutes west of New York City (via bus too) and the Tapanzee bridge.  This area is home to numerous other pharmaceutical firms which affords you great career flexibility without having to move. A multitude of housing options are available in suburban, rural, and urban settings.

 

Responsibilities in a Nutshell: This is a diverse position requiring the ability to multitask – you will be working on multiple projects, often global, simultaneously. Projects include Rx-to-OTC switches and OTC products, both for new claims/line extensions and for new chemical entities.Manage study start up, conduct and closeout.Write/QC study protocols, final study reports, safety summaries, etc.Manage relationships and monitor performance of CROs and other vendors. Contribute to sourcing decision process as appropriate in the review and selection of external vendors. Facilitate the development of contracts, obtain/assess bids appropriately.Develop and track study timelines and propose strategies to implement contingencies and risk planning to meet overall timeline goals. Manage and forecast clinical trial supplies.Provide input into operational feasibility in study design.Identify need for and request allocation of resources as needed to ensure on-time delivery of assigned studies. Lead site selection with coordinated input from appropriate stakeholders. Provide status reports for program meetings and senior management. Drive timelines and project budgets to ensure study comes in on time and within budget. Track and report on study spend against projected budget. Serve as single point of contact for site/vendor questions relating to study conduct issues.Develop content and drive execution of investigator meetings (may present selected topics).Provide significant input into design and development of Case Report Forms.Provide significant input in end-of-study learning debriefs for study team. This is a global group, and you will work with groups in other countries.Work closing with marketing on unique study implementation strategies like Internet recruitment, mall intercept studies, etc.  You will work independently - this is not a micromanaged environment.Represent the department on internal and external process improvement teams.

Compensation: Base compensation will likely run in the $80k to $95k range (and can be higher if you have more experience warranting the higher Project Manager title) plus a very dependable double digit bonus and very attractive benefits, including 4 weeks vacation plus the week off between XMAS and New Year’s.

 

Travel: Very little 'traditional' monitoring. Mostly it’s oversight of contract monitors, so travel will be at most about 20%, and most of that is to marketing meetings

 

Experiences Desired in a Nutshell:4 to 6 years experience in clinical study trial management within a Pharma or CRO environment for the Clinical Study Manager title. If you have more experience (7 -10), there is potential for a Clinical Project Manager title.Experience writing protocols or clinical study reports is a plus.Experience selecting and managing a CRO is a plusKnowledge of IND/NDA submission requirements is a plus.BS in Life Sciences is a plus.

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Contact:

 

Corey S. Ackerman, JD
Partner

cackerman@cornerstonesg.com

CORNERSTONE SEARCH GROUP, LLC (www.cornerstonesg.com)
Pharmaceutical Recruiting Specialists
9 Sylvan Way | Parsippany, NJ 07054
p 973.656.0220

 

CORNERSTONE SEARCH GROUP Is a specialty pharmaceutical recruiting and search firm located in the heart of New Jersey’s Pharmaceutical Corridor. We help our clients, which range from small biotechs to large global companies, identify and recruit experienced pharmaceutical professionals on a Retained or Contingency basis for full-time and contract positions. We also provide our clients with Outsourced and Project-Based Recruiting Solutions as well as Strategic Counseling in relation to talent acquisition and retention.

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