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Clinical Trial Operations Manager V
Ref No.: 18-01883
Location: Bridgewater, New Jersey
Position Type:Contract
Start Date / End Date: 04/23/2018 to 06/30/2018
Job Title: Clinical Trial Operations Manager V
Job Location: Bridgewater, NJ
Job Duration: 2 Months


The Senior CTOM is responsible for the overall operational planning and activities for the implementation and conduct of studies (R&D clinical trials or Medical Affairs clinical trials, observational studies, compassionate use and registries) including oversight of data management activities in compliance with GCPs, SOPs and standards within established timelines and budgets.

The Senior CTOM is involved in the scientific conduct of the study and acts as the leader of operational disciplines to create, implement and manage an operational trial plan – including risk management plan to secure clinical trial deliverables on time, within budget and with quality, in close collaboration with others Clinical Trial Team department representatives.
Provides input into identifying implications of study progress on overall timeline goals and conduct plans. Provides input into content and execution of investigator meetings and may present selected topics. With oversight, develops informed consent form and coordinates input. With oversight, provides point of contact for site questions relating to study conduct issues. Participates in the implementation of key organizational process improvement initiatives. Responsible for serving as clinical trial leader for a large-scale multi-country trial (Phases I-IV). Responsible for protocol preparation, generation of manuals for trial support committees and other trial documentation. Lead the multi-disciplinary team responsible for study completion. Writes and reviews abstracts/manuscripts, etc. for presentation/publication at internal/external meetings. experience in Clinical Trials or Clinical Project management. Experience with Investigator Sponsored Trials. Bachelors level degree/RN (or equivalent). Experience: 6 to 9 years.

Experience in Clinical Trials and Clinical Project management.

Experience with Investigator Sponsored Trials.
Experience: 8 to 10 years minimum.
2+ years of prior management and/or supervisory experience in coordinating international clinical trials is required.
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
- Strong Project Management and planning skills
- Excellent 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, ...)
- Strong English skills (verbal and written if English is the second language)
- 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