Clinical Trial Operational Manager

Job Description

The CTOM is responsible for the overall operational planning and activities for the implementation and conduct of studies (clinical trials, observational studies, compassionate use and registries) including data management activities in compliance with GCP s, SOPs and standards within established timelines and budgets.

The CTOM is involved in the scientific conduct of the study and acts as the leader of operational disciplines to guarantee release of homogeneous high quality data, in close collaboration with other CSO department representatives (e.g. Medical Operations)

May be required to take-on the Dedicated Project Expert (DPE) role depending on CTOM s level of experience, relevant skill-set and business needs.

Skills: 

• Capable of interacting effectively with scientists and managers within and outside CSO SCP; serve as internal consultant on assigned area and liaise with external organizations on projects.

• Strong interpersonal and communication skills (verbal and written)

• Ability to handle multiple task and to prioritize, strong organizational and presentation skills

• Leadership skills

• Project Management skills

• Decision-making and problem-solving skills

• Ability to work autonomously and to efficiently & effectively provide status reports

• Ability to anticipate and timely escalate issues and to define appropriate action plans

• Good cross-functional team leader who fosters team spirit and team motivation (team work)

• Knowledge and qualification with international standards (e.g. GCP, CDISC, etc.), company tools (including data management systems), processes and SOPs

• Experience in managing and leading international meetings (Clinical Trial Team, expert meeting, etc)

• Ability to work in an international environment with internal and/or external partners (CROs etc)

• Strong verbal and written English skills

• Ability to adapt and be flexible to change and managing internal and external impediments

• Understanding of data base concepts preferred

• Knowledge or ability to rapidly gain knowledge with programming/query languages

• Knowledge of industry data management standards and practices

• Must be able to interact effectively with a variety of internal and external teams

• CTOM will consult with the DPE/PL to ensure study decisions are aligned on program timelines, strategy and budget

Education:

Bachelor's degree (advanced degree preferred) plus at least 7 years of experience in pharmaceutical industry or clinical-related discipline including at least 5 years clinical research experience, including 2 years of trial operations management.

Qualifications

Additional Information

Best Regards,

Anuj Mehta

973-967-3402