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 utilize 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
Supports 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
May manages workload of supervised staff with continued assessment and adjustment as needed
Perform 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 5 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience
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
Preferred:
Advanced degree
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 environment where employees have a sense of ownership that will lead to increases in productivity and efficiency
Results oriented, accountable, motivated and flexible
Excellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skills
Excellent presentation, verbal and written communications skills
In depth proven experience in pharmaceutical and/or device research required
Demonstrated successful independent negotiation and conflict management strategies
Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.
Reasonable estimate of the current range
$112,000—$161,300 USD
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