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

Manage processes for investigational product (IP) including drug accountability and reconciliation

When a cross-functional PM is not assigned to a given program, the CTM will assume project management responsibility as needed

Support business development and marketing activities as appropriate

May negotiate site budget and investigator contract with support from the legal department and/or site contracts group

May review site visit reports and ensures monitoring (i.e. scheduling and scope) is executed per monitoring plan

May be responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with PM

May perform clinical data review of patient profiles, data listings and summary tables, including query generation

May have line management responsibilities

Performs other duties as assigned by management

Qualifications:

Minimum Required:

Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred

Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience

Preferred:

Advanced degree

Other Required:

Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)

Excellent communication and interpersonal skills to effectively interface with others in a team setting

Excellent organizational skills, attention to detail, and a customer service demeanor

Ability to travel domestically and internationally including overnight stays

Competencies:

Demonstrates mastery knowledge of ICH-GCP, relevant Precision SOPs, and regulatory guidance, as well as the ability to implement

Working knowledge of clinical management techniques and tools

Direct work experience in a cross-functional environment

Proven experience in functional management including proven experience in delegating while fostering cohesive team dynamics

Proven experience in planning, risk management and change management

High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective

Ability to lead and inspire excellence within a team

Ability to create an env…