Clinical Research Quality Manager Jobs

Project Management experience is a must

Quality event management experience is a must

Ensures final endorsement of document(s) prior to coordinating approval workflows in the Document Management System (DMS).

Typically requires 8-10 years of experience, or the equivalent combination of education and experience, in the biopharmaceutical industry

Sponsor/CRO GCP experience required (experience in a Clinical Project Manager role is ideal)

Strong interest and understanding of Process/Controlled Document Management – this can be trained for the right person

1-3 years related work experience required.

Knowledge: Ability to demonstrate in-depth knowledge of concepts, practices and policies with the ability to use them in complex varied situations.

Collaborates with program staff on the design and analysis of research protocols. Participates in the design of questionnaires and interview forms.

Conducts surveys of staff and subjects, including the delivery, collection and analysis of survey tools.

Bachelor's degree required. Master's degree in Public Health, Epidemiology, Statistics, Biostatistics or related field preferred.

Demonstrated ability to work with software programs including SAS, Access, Powerpoint, Epi Info and Excel.

Demonstrated organizational skills and ability to pay close attention to detail.

Demonstrated critical thinking and analytical skills.

Demonstrated knowledge of database, word processing, and spreadsheet programs.

Title: Clinical Research Compliance Manager

Approximately five years of prior experience in a clinical research setting.

As required under NYC Human Rights Law Int 1208-2018 - Salary range for this role when Hired for NYC Offices

Minimum of 5 years' experience working in a Clinical Research Manager or Clinical Project Manager role with relevant experience.

Experience with FDA and US requirements for the conduct of clinical studies is a must.

Multi-disciplinary international project management managing diverse relationships.

Exciting job opportunity with project responsibilities and freedom for professional growths and acquisition of new skills

Supervision (remote and in-person) of participating study centers

Ability to manage multiple projects in parallel and prioritize across study, regulatory, and company goals.

• MT Group is a CRO for biospecimen sample acquisition and management

1+ years experience in any of the following:

• 2+ years of experience in a science, research, or medical setting

• Full Benefits (Medical, Vision)

As a research coordinator or research associate

• Small, Growing Company (30 people)

5-10 years of clinical trial regulatory management experience.

Quality Management System/Regulatory Compliance Program

5 Years minimum regulatory experience in clinical trials

Regulatory certification from AAAHRP, SOCRA, PRIM&R or similar organizations

Experience gained from multiple perspectives: industry sponsor, CRO, academic, government or site level

Has GCP training and follows GCP guidelines and other guidelines related to the conduct of human subject’s research

Collaborates with hospital personnel and departments, compliance, and University of Maryland, Baltimore clinical research personnel regarding requirements for conducting clinical research.

Communicate with UMMC finance office to facilitate payment for research activities, as per contracts and agreements.

Experience in clinical research preferred.

Ability to apply knowledge of research procedures and clinical practice to recommend changes to research protocol

Knowledge of best practices in clinical research.

Excellent oral and written communication skills.

Manages and develops contracts, Invoices, and Finances related to procedures and protocols.

Advanced Clinical/Science degree or professional credentials required (BS, MS, PhD, PharmD, and/or scientific background/experience)

Rele ant transferable experience (clinical practice, clinical or scientific training, academic research, and regulatory/scientific).

Experience in Medical/Cosmetic Dermatology, Plastic Surgery, Cellular Biology, and/or Facial Aesthetic disciplines strongly desired.

Strong analytical skills and presentation skills

Experience performing research and/or analyzing clinical research data

Ability to recognize competing priorities and deadlines and seek guidance in management of these where needed.

Supervise study research coordinators, including monitoring recruitment, data entry, tracking patient participation throughout the study lifecycle, and conducting weekly meetings.

2-3 years of experience coordinating or managing clinical trials.

Previous experience with participant recruitment.

Excellent communication, writing, organizational and presentation skills.

Previous experience conducting monitoring visits with study sponsors.

Bachelor's degree or equivalent practical experience. 3-5 years of experience working in project management or similar discipline.

Strong working knowledge of project management tools such as spreadsheets, Google Docs, and Project tracking software.

Knowledge and experience of clinical trials.

Excellent communication skills, with experience in communication with executives.

Proven ability to manage complex projects involving multiple stakeholders, and in a fast pace environment.

Strong problem-solving and analytical skills, and ability to handle ambiguity and create order out of it.

Quality Improvement and project management training/experience

Management and oversight of automated population health solutions and electronic systems reporting.

Manage internal and external partner relationships across multiple departments and external organizations.

Partner closely with health centers as well as performance managers to drive positive outcomes

Experience working in or with primary care organization and conducting outreach to improve engagement in care

Experience facilitating teams in improvement initiatives

Bachelor’s degree or equivalent in relevant health care area. Advanced or formal education in quality management or business management is preferred.

Knowledge and background in clinical development programs, clinical trial processes as well as quality management systems and quality control tools.

Experience with delivering effective CAPA management solutions.

Experience with risk management tools and processes within the clinical quality framework.

Excellent project management and organizational skills.

Escalate potentially significant inspection findings/compliance risks/impact to our Company Senior Management.

(4) Prepare project documents and materials and assist staff to coordinate project management activities and meetings

(3) Experience with meeting coordination, meeting minutes, reports, budgets, and data analysis

(5) Prepare project dashboards and summaries as well as milestone status and updates

(6) Prepare progress reports, summaries, descriptions, and other materials to communicate with internal and external stakeholders.

(7) Assist with managing financial aspects include monitoring budget and completing appropriate financial requests and accounting documentation

(8) Establish and review project metrics to measure and evaluate project status and performance.

Provide support (e.g. data entry, filing, QC, etc…) to CRU personnel and other Clinilabs personnel ad requested and needed.

Manage and track project timelines and quality issues.

Must have related experience for at least two years.

Must possess excellent clerical, strong computer and good interpersonal skills.

Reading and understanding study protocols.

Communicate with all operational departments regarding project status/issues.

Will this position accept substitution in lieu of education or experience?

Minimum Years of Experience Required

Med-Anesthesiology and Perioperative Medicine - Pennsylvania-Pittsburgh - (23003837)

Knowledge, Skills And Abilities (required)

Experience developing reports and dashboards

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

May require extended or unusual work hours based on research requirements and business needs.

Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.

Supervise the implementation of and adherence to study protocols. Educate research staff on established policies, processes, and procedures.

Current and working knowledge in interpretation/implementation of government and other local state/government regulations/requirements governing the ability required

Manage programs/projects, defining milestones and success criteria, resource allocation and successful on-time delivery.

Negotiate, structure, and manage clinical contractual documents that establish business relationships with vendors, customers and/or partners.

Coordinate, manage, and facilitate business processes to provide timely deliverables.

Provide training and overall guidance to on the clinical affairs organization on contracts and financial requirements.

6+ years of applicable experience in legal contracts, conducting business/financial negotiations, and other binding agreements required

• 2-3 years experience with vendor management

• Understanding of clinical trials processes and/or clinical data management preferred

• Manage day-to-day data request review process for specific requests.

• Experience in supporting researcher and/or data contributors in fulfilling data requests

• Excellent written and oral communication skills and interpersonal skills

• Prior experience with process improvement a plus

Strong organizational/prioritization skills for the management of multiple concurrent projects

Serve as the primary contact for clinical trials across the ACO to ensure appropriate communications, trial management, and meeting of timelines

Perform data entry and query resolution

Facilitate pre-study, site qualification, study initiation, monitoring visits, and study close out activities

5+ years of clinical research coordinator experience

Extensive knowledge of clinical research studies, protocols, etc.