Senior Study Manager

OBJECTIVE:  The purpose of this position is to be responsible for the execution of Phase I-IV studies according to ICH guidelines in support of the clinical strategies defined in the Takeda Integrated Development Plan (IDP).  Member of the clinical team responsible for conducting clinical studies, which includes participating in writing of study protocols; total management of assigned study conduct, including oversight of the study team and CROs/other vendors; identifying and resolving study site issues; managing the study budget and study closeout.  May participate in training of junior personnel.

ACCOUNTABILITIES:  Responsible for conducting clinical studies, including participating in writing of study protocols and amendments according to ICH guidelines. Ensures compliance with all regulatory requirements for the study.Participates in selection of CRO.  Supervises CROs conducting clinical studies; supervision includes assisting with budget and contract negotiations, communicating TGRD’s expectations, planning content for study meetings in collaboration with the TGRD Clinical Research staff, evaluation of site visit data and selection of new study investigators and reviewing trip reports for identification of protocol-related issues.Monitor or oversee monitoring of investigational sites during the conduct of assigned studies.Responsible for the evaluation and selection of new study investigators. Ensure consistency of CRFs across program.Ensure timely collection and maintenance of study documentation files and proper drug supply. Assist in planning, preparation, and participate in investigator meetings in collaboration with TGRD’s Clinical Research staff to ensure training of investigators, study coordinators and CRO monitors on the protocol and expectations of operation.Facilitates the development of multiple study timelines in collaboration with other members of the clinical.  Reviews timelines for overlapping resources in cross-functional areas and presents solutions to these issues.Responsible for managing assigned study(ies) within budget; provides latest best estimate of study budget and completes key input sheets; provides guidance to study team on requests for additional services from CRO that may affect the budget.Ensure data quality and adherence to government regulations and ICH and other relevant guidelines; reviews tables and listings for accuracy and clarity.Ensures study-related documents (e.g., CRF guidelines, study manuals, data management edit checks, etc.) adhere to protocol, government regulations and ICH and other relevant Guidelines. Communicates with Product Safety and Clinical Research staff as necessary for assigned study.Responsible for identifying study site issues and bringing to the attention of the Program Manager for discussion.  Develops and implements corrective action plan. Responsible for identifying CRO issues and bringing to the attention of the Program Manager for discussion.  Provides input to problem-solving and implements corrective action plan.Participate in cross-functional Study Team Meetings; Interface with disciplines, and personnel directly or indirectly involved in the clinical trials.  May be responsible for leading the Study Team Meetings. Participates in development of overall program budget for the compound.Develops strategies to mitigate program-related issues (e.g., recruitment and retention of subjects). 



EDUCATION, EXPERIENCE AND SKILLS: 


Required:


Bachelors Degree preferably in Life Sciences, or R.N., or international equivalent

5+ years of clinical trial management experience including accumulation of one year of monitoring experience required

Demonstrated ability to manage multiple clinical trials on time and within budget

Superior communication skills: written, oral, interpersonal and presentation

Excellent problem solving and analytical skills


Desired:


In depth knowledge of a particular therapeutic area

Familiarity with TGRD clinical systems

Participation in NDA/CTD process
Skills:


Clear, direct, tactful communication skills are required – experience in writing study protocols, summaries, clinical brochures, FDA annual reports and other clinical documents for submission to the FDA.

Strategic thinking – begin to participate in strategic planning.  Able to anticipate potential problems and obstacles and plan accordingly.

Ability to organize and manage a CRO and multiple sites participating in a clinical trial.

Ability to prioritize work effectively to meet timelines.

Demonstrates professional and effective presentation skills.

Analytical skills – ability to identify study-related, CRO-related or site-related issues, determines the causes and possible solutions to the problem.

Interpersonal Flexibility – ability to adapt to other personalities in a respectful manner that is conducive to goal achievement.

Resource Management – ability to manage internal and external vendor resources related to study trial conduct.





TRAVEL REQUIREMENTS:


Access to transportation to attend various meetings held in proximity to the Takeda offices.

Able to fly to various meetings at investigator, vendor or regulatory agency sites.

Some international travel will be required.


Submit your resume and start a quality career with Takeda!


 


We are an equal opportunity employer.


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