Clinical Trial Manager (CTM)

Clinical Trial Manager (CTM)

Position Summary

The Clinical Trial Manager will be responsible for managing operational activities of assigned clinical programs. The CTM will partner with key internal and external stakeholders to ensure continuous harmonized operations of clinical operations activities and to maintain high standards for performing in a cross-functional environment.

The CTM is accountable for:

Facilitating all operational activities pertaining to the execution of clinical trials from study start up to closeout

Maintaining regular internal contact with relevant departments such as necessary

The day-to-day interaction with Contract Research Organizations (CROs) in the execution of ongoing clinical trials

Assisting when required with the development and review of study protocols, informed consent forms, case report forms, monitoring plans, study materials and monitoring tools

Establishing study milestones and ensures accurate tracking and reporting of study metrics

Assisting with the resolution of questions about invoices to ensure accuracy and timeliness of vendor and site payments

Reviewing and tracks required documentation from clinical sites

Reviewing and resolves discrepancies in clinical data with CRO counterparts and clinical sites

Reviewing and monitoring visit reports and ensures follow-up with CRO clinical trial manager(s) and/or escalation of issues as necessary

Ensuring that the site and subject status information in CTMS is updated and accurate; ensures timely updates to Clinical Operations line management

Assisting with ensuring regulatory compliance of clinical sites with company SOPs as well as GCP and ICH guidelines

Providing input for the definition of new or revised process development, problem solving, training, etc., as needed

Clinical site visits when needed (in conjunction with CRO, if applicable) for site evaluation, initiation, monitoring or co-monitoring, or close-out activities.

Participating in Clinical Operations initiatives and programs

All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with the company's Standard Operating Procedures

Participating in continuous improvement initiatives and professional growth

Performing other related duties as required

Maintaining 100% compliance on all required department and company training

Adhering to pH Pharma’s values, applicable regulatory requirements, and company policies and procedures

Who You Are

Successful candidate will have:

            Working knowledge of medical terminology, drug development processes, industry standards, GCPs,                 clinical trials monitoring, and regulatory compliance

     Willingness to gain experience developing trial plans including, site monitoring strategies, risk mitigation      strategies, trial budgets, site selection, and clinical supplies management

     Strong communication skills (encompasses verbal, written, interpersonal, listening)

     Effective time management and organizational skills

     Attention to detail and accuracy in work

     Ability to establish and maintain effective working relationships in a team environment

     Positive, self-starter, flexible; ability to adapt to changing priorities

     Interacts with customers, partners and co-workers internal/external to the department and/or company in      accomplishment of business goals and objectives

     Strives for the achievement of excellence

     A high level of commitment and professionalism

           Willingness to travel for job related activities if required (expected travel for this position is up to 20%)

Education / Experience

Bachelor’s degree or equivalent with 6-8 years’ experience in the pharmaceutical industry

Experience in monitoring as a Clinical Research Associate is preferred