The CTM serves as the clinical functional lead, accountable for the clinical monitoring/site management delivery of assigned tasks and project(s) as per scope. The CTM may provide oversight working across regions and/or countries to ensure clinical project and site deliverables are met. The position provides leadership, mentoring, and technical support to the clinical project team to ensure quality deliverables and achievement of milestones and financial goals. May provide administrative line management, which includes oversight of training, compliance, performance, development, and career management of direct reports. This position will require an understanding of the basic skills necessary for the application of regulatory requirements, contractual/budgetary guidelines, and CRO level methodologies. Performs duties in accordance with company’s values, policies, and procedures.

DUTIES AND RESPONSIBILITIES:

• Ensures quality of the clinical monitoring and site management deliverables within a project and/or program and maintains proper visibility of its progress by the use approved systems and/or tracking tools. May include the development of the Clinical Trial Project Plan, Monitoring Plan, and/or site qualification documents.
• Interacts with the client and other functional departments related to clinical monitoring and site management activities and deliverables.
• May participate in business development activities including project clinical operations/site management strategy and budget input, defense meetings, and proposal development.
• As required, provides development and delivery of initial and ongoing training to the study team regarding protocol specifics, Case Report Form (CRF) completion, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans, and timelines for the project. Plans and leads regular clinical project team calls to provide status updates, ongoing training, and accountability to deliverables.
• May evaluate staff's competency to perform visits/site contact independently via sign-off visits and Performance Assessment Visits (PAVs) according to company standards and process.
• Globally reviews Clinical Trial Management System (CTMS), CRFs, drug management, safety, Trial Master File (TMF), Interactive Web/Voice Response Systems (IxRS) enrollment, data monitoring and/or other dashboards to oversee site and project team conduct, ensures timely entry of all operational aspects (required visits, duration, and frequency) according to plan, and identifies risks to delivery or quality.
• Reviews the content and quality of site monitoring documentation (site monitoring calls, site visit reports, site letters, and pertinent correspondence), to ensure they represent site management activities and conduct. Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines.
• Understands the monitoring strategy required for the project and, where required, participates in the development of the project risk assessment plan. Accountable for the clinical teams' understanding and ongoing compliance and delivery, according to the stated monitoring strategy, Clinical Monitoring Plan (CMP), and risk plans.
• Collaborates with other functional areas to ensure site compliance and delivery according to protocol, ICH/GCP and country regulations, including medical monitoring, safety, and quality Assurance (QA). Ensures inspection readiness for clinical scope.
• As defined by scope may be responsible for team member clinical/site management project deliverables as the clinical functional team leader. Drives and manages the clinical and site management aspects of assigned project. May be a standalone lead or part of a regional or global clinical functional lead team.
• As defined by scope may oversee the global project process and status of monitoring and data flow. Reviews status and trends at the study level, holds CRA team accountable to manage at site level for effective and timely Source Document Verification (SDV) and data flow, reviewing status of site and project eCRF entry, SDV, triggered monitoring conduct, query response, and data cleanliness. Proactively collaborates with data management functional lead to plan towards data cut and lock deadlines. Develops and executes corrective action plans at study level to address any issues.
• Assists Clinical Project Managers (CPMs) with the selection of investigators, as well as with site issue resolution.
• Works with investigative sites and ad-hoc team members to complete all documentation necessary.
• Determines completeness and readiness to support clinical supplies/investigational product shipment.
• Aids in laboratory sample reconciliation and sample management as needed.
• Assists in preparing submissions for independent ethics committees (IECs) or institutional review boards (IRBs) by compiling the package of documents for IEC/IRB and forwarding to either the investigator or IEC/IRB as directed.
• Supports the CPM with third-party vendor oversight activities.
• Assists clinical teams in evaluating the investigator’s performance at closeout to facilitate future site identification activities.
• Aids the CPM completion of all required tasks to meet project goals.
• Works closely with CPM on non CTM scoped projects in the creation and development of the clinical study specific plans as assigned. This includes but is not limited to the clinical monitoring plan. Also responsible for creating and updating study specific tools and templates related to clinical site management and monitoring.
• Works closely with the clinical project management team and the cross functional teams while keeping them apprised of any monitoring or study related issues and seeking guidance as needed.
• Moderate travel may be required, approximately 20%.

JOB REQUIREMENTS / QUALIFICATIONS/EDUCATION:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Familiarity with Good Clinical Practices (GCP), ICH guidelines and FDA regulations are a bonus. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education and Experience:

Associate or bachelor’s degree in health, biological science, or other related field and 2 years CTM related experience in CRO industry and/or equivalent combination of education and experience. Demonstrated ability to lead and align teams in the achievement of project milestones, as well as demonstrated capability of working in a global environment. Experience with FDA and other regulatory documents including CRFs and Informed Consent Forms (ICFs) preferred. Ability to apply problem solving techniques to resolve complex issues and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project. Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues.

Education and Experience:

Associate or bachelor’s degree in health, biological science, or other related field and 4 years CTM related experience in CRO industry and/or equivalent combination of education and experience. Demonstrated ability to lead and align teams in the achievement of project milestones, as well as demonstrated capability of working in a global environment. Experience with FDA and other regulatory documents including CRFs and ICFs preferred. Ability to apply problem solving techniques to resolve complex issues and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project. Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues. Knowledge of basic clinical project financial principles.

KNOWLEDGE, SKILLS, AND COMPETENCIES REQUIRED

Skills, Knowledge, and Abilities:

Basic knowledge and understanding of CRO clinical systems and procedures. Basic knowledge and understanding of applicable regulatory regulations. Working knowledge of clinical research; ICF review; IRB submissions; regulatory review/submissions; clinical site oversight; protocol review; and use of clinical systems.

Competencies:

• Functional/Technical Skills: Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
• Learning on the Fly: Learns quickly when facing new problems; a relentless and versatile learner; open to change; analyzes both successes and failures for clues to improvement; experiments and will try anything to find solutions; enjoys the challenge of unfamiliar tasks; quickly grasps the essence and the underlying structure of anything.
• Planning: Accurately scopes out length and difficulty of tasks and projects; sets objectives and goals; breaks down work into the process steps; develops schedules and task/people assignments; anticipates and adjusts for problems and roadblocks; measures performance against goals; evaluates results.
• Dealing with Ambiguity – Can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; isn’t upset when things are up in the air; doesn’t have to finish things before moving on; can comfortably handle risk and uncertainty.
• Priority Setting: Spends his/her time and the time of others on what’s important; quickly zeros in on the critical few and puts the trivial many aside; can quickly sense what will help or hinder accomplishing a goal; eliminates roadblocks; creates focus.