Clinical Research Manager job description

Under the direction of the Sr. Project Manager, the Project Manager, manages all aspects of assigned clinical trials involving patient and normal healthy subject populations in both inpatient and outpatient settings. This position acts as the liaison between the sponsor and the research team. It assures sponsor requirements and specifications are communicated to the teams on a timely basis and that any issues raised by the teams are communicated back to the sponsor so they can be resolved in a timely and appropriate manner.

Education: • Bachelors degree, or licensure in a health profession (i.e. RN, LVN), or an equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills and abilities.• Minimum of 3 years experience in clinical research, program management, clinical auditing, or QA/Regulatory Affairs and a minimum of 1 year clinical project management experience or experience handling multiple or global projects in another area of clinical research Knowledge, Skills and Abilities: · Basic computer skills with working knowledge of Microsoft Office software· Effective time management skills· Strong leadership and team-building skills· Excellent written and verbal communication skills· Ability to prioritize the elements of each unique study plan and to alter the elements on a continuous basis according to study progress· Ability to effectively handle multiple tasks and priorities in a professional manner, assuring sponsor satisfaction and staff cooperation· Effective planning skills for the accomplishment of both short and long term goals for each study.· Ability to analyze and interpret study financial statements and contractual agreements with sponsors and subcontractors· In depth knowledge of the clinical research process (i.e. Good Clinical Practices, obtaining informed consent, drug dispensation and accountability, process for handling protocol amendments, obtaining ethical reviews and providing ongoing reports to IRBs) PPD is an equal opportunity employer, M/F/D/V - embracing diversity and the responsibilities of corporate citizenship in our communities. PPD values our former military and transitioning service member's service.
**Job:** **Project Management*

**Organization:** **US BU*

**Title:** *Clinical Research Manager - Office Based*

**Location:** *FL-Orlando-Orlando FL*


PPD is an affirmative action employer that values diversity as a strength fosters and environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Responsibilities
What you will be doing:
Main POC for assigned protocols and link between Country Operations (CO) and clinical trial team (CTT). Project management of assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out. Accountable for performance of assigned protocols in country in compliance with ICH/GCP, country regulations, client policies and procedures, quality standards and adverse event reporting requirements internally and externally. Reviews Monitoring Visit Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management Performs Quality Control visits as required Leads local study teams in high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert & coordinates activities across different local country roles. Creates and executes local risk management plans Supports compliance with CTMS, eTMF and other systems Escalates issues to TA Director/CRD/CQM/CTT Collaborates with functional outsourcing vendors, investigators and other external partners in studies Country POC for programmatically outsourced trials for assigned protocols Serves local business needs in his/her country (if delegated, signs contracts and manages budgets) Collaborates internally with HQ functions and local with PV, Regulatory and GMA to align on key decisions Builds business relationships and represents the client with investigators Shares protocol-specific information and best practices across countries/clusters
Qualifications
What you need to have
Bachelor's degree in science or similar required. Masters, PhD, MD (preferred) At least 5 years experience in clinical research (required) Previous CRA experience (preferred) Oncology experience (Required); Oncology Early Development experience (preferred) Ability to travel up to 30% Clinical trial management experience (required) Project/Site Management knowledge Demonstrated success of strong organizational skills Strong understanding of local regulatory environment Strong scientific and clinical research knowledge Strong understanding of clinical trial planning, management and metrics Ability to focus on multiple deliverables and protocols simultaneously To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status


Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
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Cancer Clinical Research Informatics Manager is responsible for the managing the specialized informatics needs of the Montefiore Einstein Cancer Center. This person will be responsible for integration and optimization of the cancer-related clinical trials into the clinical trial management system(s) (and other electronic data capture systems) into operational practice, useful data analytics, data quality, and ultimately study performance to support cancer clinical research and clinical trials. The incumbent will support the cancer clinical research community consistent with expectations of NCI-designated Cancer Centers as outlined in the Cancer Center Support Grant (CCSG) guidelines. This role will develop and refine informatics-based tools and metrics to manage and report on defined measures for the Protocol Review and Monitoring System, Data and Safety Monitoring Committee, and patient accrual to clinical studies across the entire cancer clinical trials portfolio.

This position will collaborate with the Cancer Clinical Trials Office Assistant Director of Quality Assurance to leverage systems and reporting to support internal monitoring and auditing activities to meet regulatory compliance requirements in the conduct of clinical trials. The Informatics Manager will work closely with Disease Teams leaders and Cancer Clinical Trials Office staff to leverage systems and analytics to drive decision making in the review and conduct of clinical trials and serve as a project lead and subject matter expert for process improvement initiatives.

This position plays a key role in developing and maintaining relationships with colleagues, clinical investigators and leadership to align priorities to mission that will lead to cultural change and increase access to clinical trials and clinical care in the Bronx community. This position will implement strategies, processes and tools to support patient recruitment, regulatory compliance, clinical trial billing compliance, clinical trial performance and quality improvement, and operational efficiencies that will ultimately impact the patient experience and employee engagement.

Develop and work in a collaborative environment to ensure clinical trial and clinical research data supports regulatory compliance with quality measures;

Participates in the newly formed Feasibility Committee that will embrace data to drive operational excellence;

Lead process improvement initiatives to optimize systems and business/operational workflows for data quality and study performance; leverage multi-disciplinary teams as subject matter experts for working groups;
Develop best practice in leveraging systems for appropriate clinical trial billing compliance; Serve as informatics liaison to clinical staff to translate clinical practice needs, nursing and clinical trial protocols information between nurses and systems engineers and analysts, using object-oriented models or other techniques; Develop reports, dashboards and visualization tools to support NCI reporting requirements and critical decision support to expand the cancer clinical trial portfolio; Develop and implement training and education materials in best practice in using Velos (clinical trials management system) and other electronic data capture systems for clinical research; Monitor industry standards and trends in clinical trials operations and management to identify gaps/areas of opportunity; develops action plans to address areas of concern; Participate in Epic/Velos optimization working groups; identify gaps between business requirements and application capabilities and recommend action steps specific to Cancer Center needs and requirements; Develop and maintain appropriate SOPs for systems according to GCP in the conduct of clinical trials.
Albert Einstein College of Medicine offers flexible work schedules and a hybrid remote work arrangements for our professional and administrative staff with supervisory approval. The incumbent for this position is eligible for consideration and applicants should inquire.
QUALIFICATIONS
Education:
Master's degree in Informatics or related field. Nursing or Clinical Degree highly preferred
Experience:
At least 7years of experience in informatics and/or clinical research.