Clinical Trial Manager/Senior Clinical Trial Manager

Position Summary:

Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies per defined scope of work and ensures that clinical studies are conducted in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and all applicable regulatory requirements.

Essential functions of the job include but are not limited to:

Primary clinical point of contact with the client

Collaborate with PM on monthly invoicing and variance management of clinical budget

Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials)

Identify and develop training needs for CRAs and third-party vendors specific to the study, protocol and practices including presenting these at Investigator Meetings and Study Kick-off meetings

Generate potential site list from key stakeholders and drive site feasibility process

Identify potential risks to the enrollment targets based on feasibility analysis and site’s contracted commitment

Develop and finalize the country recruitment/retention strategy

Develop timely and effective communication and good working relationships with investigators and study team to ensure effective and timely feasibility, site start up, enrollment, maintenance and close out procedures

Lead internal clinical team meetings and sets expectations for clinical team of CRAs and CTAs

Address all CRA and site questions and maintains Frequently Asked Question (FAQ) log as appropriate

Support in planning and conducting investigator meetings

Review and/or approve of IP release packages

Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments as applicable

Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables

Generate and utilizes metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates issues to PM and CRAs as appropriate

Responsible for eTMF implementation and management

Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) and is accountable for implementation and timely closure

Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits

Work closely with PM for project-specific resourcing issues

Escalate pertinent CRA performance and site compliance issues when necessary

Collaborate with data management and CRAs to ensure data quality and compliance with data cleaning timelines