Project Manager (FSP), Remote (US)

Project Manager (CSM) - Global Lead PM

Client : Takeda

Client Role : Clinical Study Manager (CSM) - This is a Global Lead PM / Primary PM role

Dept : FSP

Location : US (ET or CT zone preferred), client could be open to candidate in PT zone willing to work ET hours.

Travel 5-20%

MUST HAVE 4+ years of global lead PM experience

MUST HAVE strong vendor management experience

MUST BE ABLE TO WORK WELL UNDER PRESSURE FOR HIGH VISIBILITY STUDY

From Takeda JD : OBJECTIVES :

Lead or support study operational strategy and planning and oversee execution of select clinical studies (global / regional and / or local country) for assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan.

In close collaboration with the Clinical Operations Program Lead (COPL) and the Clinical Operations Manager (COM) (if applicable) :

• Support or oversee the execution of select complex study / ies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget.
• Oversee Strategic Partners and / or other CROs and other vendors to meet Takeda's obligations described in ICH-GCP and Takeda's business objectives.

Studies may include but are not limited to PTA (Post Trial Access), RATIO (R&D Asset Transition and Integration Office), those in wind down, etc. More than one study and / or more than one program may be assigned.

ACCOUNTABILITIES :

Skills :

Experience : 6+ years' experience in pharmaceutical industry and / or clinical research organization, including 4+ years clinical study management / oversight, including significant study management support experience (e.g. clinical trial assistant / associate or lead CRA). Experience could include either early phase clinical studies or Phase 2 and 3 studies and global / international studies or programs. Experience in more than one therapeutic area is advantageous.

Advanced degree(s) (e.g., Master or Doctorate) and relevant training or experience (e.g., fellowship. internships, etc.) may be considered to supplement experience requirements.

TRAVEL REQUIREMENTS :