Job description

A leader in the pharmaceuticals industry is on the search for a Clinical Research Senior Manager to join their team. This will be a hybrid (Mahwah, NJ)/remote opening, focused on managing the planning, outsourcing and successful delivery of Phase I to Phase III Clinical Trials for innovative medicine pipelines in the USA.

Job responsibilities may include, but are not limited to:

• To identify and develop relationship with Global CROs for IMG Phase I to Phase III Clinical & PK studies within USA
• To manage outsourcing of Phase I to Phase III studies including management of CROs, contracts and other vendor management activities
• Monitor expenditure of funds relative to budgetary targets and oversee the progress of Phase I to Phase III studies with respect to timelines, quality and cost.
• To review overall study plans, project management plan, monitoring plan and to perform random quality checks of study operations, monitoring activities etc.
• To develop and maintain sponsor oversight file for each outsourced Phase I to Phase III Studies.
• Ability and willingness to travel approx. 25% or as required - for conducting site selection, initiation routine monitoring and accompanied monitoring visits.
• Liaise with Global Project Manager, Clinical operations, Clinical Sciences, DMPK, CMC Regulatory Affairs and Clinical Pharmacology for planning and oversight of Clinical & PK Studies.

Qualifications:

• Graduate/Post Graduate with B. Pharm, or Medical Degree or other life sciences qualification with relevant experience.
• Minimum of 5-8 years of Healthcare/Bio-Pharmaceutical management experience of which at least 3 years should be purely in clinical trials experience. Should have experience a site monitor in phase I to phase III clinical.
• Hands-on experience in the management of Phase I and Clinical Pharmacology (TQTc Studies and DDI Studies) studies for Branded Generics and innovative (NBE/NCE) portfolios.
• Hands-on experience of managing FTIM studies trials either in a CRO or a Pharmaceutical company in USA.

Qualified candidates will be contacted immediately.

Job Type: Full-time

Benefits:

• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Education:

• Bachelor's (Preferred)

Experience:

• Clinical trials management: 1 year (Preferred)
• FTIM study management: 1 year (Preferred)

Work Location: In person

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