Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe.  

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 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