Overview
nQ is looking for an organized Clinical Project Manager to implement and oversee projects and to ensure quality of trials. The Clinical Project Manager reviews budgets making changes where necessary and outlines a project together with client. He/she regularly visits Clinical Trial Investigators, supports Case Report Forms and oversees Clinical Research Associate travel expenses and time sheets.
The clinical project manager is responsible for managing the clinical trial process by implementing effective strategies for nQ. He/she oversees reviewing trial results using strict clinical procedures. In all tasks, clinical project managers must comply with safety standards and respect privacy and confidentiality. He/she will interact with clinical staff, review trial progress, and make changes to the trial structure and processes based on subject or team feedback.
He/she will also analyze data based on trial results, interpreting research information, and creating detailed documentation. Other tasks include mentoring junior staff in acceptable clinical practices, conducting performance reviews, participating in hiring activities, and interviewing prospective personnel. He/she also prepares manuals and present conclusions at conferences and seminars. He/she assists with protocol development, budget preparation, as well as oversee assessments that include screening and testing procedures, data collection policies, storage, and inventory.
Clinical Project Manager Responsibilities:
- Coordinating as or collaborating with Project Managers to set targets for clinical monitoring and ensuring recording of trial in compliance with project goals;
- Creating and implementing study-specific clinical monitoring tools and documents;
- Creating and overseeing trial budget;
- Identifying, enlisting and choosing sites, and coordinating site management activities;
- Coordinating and supervising clinical monitoring team;
- Providing project-specific training to all trial stakeholders;
- Recording and sharing interactions with clients and acting as their representative;
- Arranging and overseeing site visits;
- Gathering and examining trial documents;
- Assuring compliance SOPs and local regulations, and CFR, ICH and GCP guidelines.
Clinical Project Manager Tasks:
- The Clinical Project manager will be responsible for clinical trial delivery including the planning, management and reporting of trials in accordance with company plans/objectives, GCP, local requirements and company standard operating procedures. This includes writing and/or reviewing protocols, site selection, start up, study conduct, data cleaning, data review and study close-out for one or more clinical trials: Manage all the clinical operations activities from study start up to close out;
- Works to ensure that trials are conducted in adherence to study protocols, applicable SOPs, FDA regulations, ICH/GCP guidelines and local government regulations;
- Support study design. Review and/or writing of protocols, ICFs, CSRs, etc;
- Contribute to the development of Case Report Forms;
- Reviews regulatory packages for trial-related submissions to IRB/IECs;
- Plan timelines, conduct risk assessment/management and contingency planning.
- Ensure timelines are communicated to all functional areas (including vendors);
- Manage budget and schedule during clinical trials;
- Write study documents, reports, and summaries of adverse events, progress, and employees;
- Develop and implement enrollment strategies, monitoring to adjust for dropouts;
- Monitor and track progress and obstacles during clinical trial, responding to day-to-day problems.
- Plan and/or conduct site evaluation, initiation routine monitoring visits. Develop and maintain effective relationships with clinical study sites:
- Plan and present at investigator meetings;
- Act as primary contact for the CRO and other clinical vendors;
- Review monitoring visit reports; liaise with monitors to understand any trends on data management issues or other site issues to develop solutions;
- Review clinical trial data. Monitor data quality and ensure appropriate quality measures are in place;
- Provide oversight and accountability of all third-party vendors;
- Regular review of the Trial Master File (TMF) and ensure inspection readiness.
About You:
A bachelor's degree in business management, biology, nursing, health care management, or a related field is required for this job. Previous experience - including in a managerial capacity - is preferred. Industry certifications desired. Must possess excellent communication skills, the ability to
- Effective written and presentation communications skills with experience facilitating 1:1 and group sessions;
- Solid working knowledge of drug pipelines, clinical trials, and the Pharma industry;
- Notable experience interfacing with trial sponsors within big Parma;
- Strong problem solving and analytical skills with experience using clinical data for protocol assessment;
- Excellent interpersonal skills with the ability to handle multiple tasks with varying deadlines;
- Admirable professionalism and ability to maintain confidentiality;
- Natural self-starter, passion for early-stage company and ability to work independently;
- Working knowledge of clinical coding schemes such as ICD-9-CM, CPT, NDC, and LOINC;
- Legally eligible to work in the geography in which the position is located.
