Clinical Research Data Manager Jobs

2-3 years of experience in clinical research data entry

Strong organization and communication skills

Ensure data is correctly input into the system and quality of clinical research is maintained

Prepared for and participates in internal and external audits and action plans needed from these results.

Utilizes Query Trackers to reconcile, clarify, and complete data issues

Direct others with interpretations of rules and regulations

Experience with MDM (Master Data Management).

Data & Analytics leader with 15+ years of industry experience.

At least 5 years of experience with clinical trial domain experience is required.

Experience with modern cloud analytics platforms such as Snowflake and/or Databricks is required.

Some MDM experience will be highly desirable.

Experience with ADF (Azure Data Factory) will be desirable.

· Perform Data Management activities and support to internal and external project teams.

· Previous CRO experience is strongly recommended.

· Client facing experience is preferred, but not required.

· Excellent oral and written communication skills.

· Attention to detail, ability to prioritize and manage multiple projects with competing and aggressive timelines.

· Perform data cleaning activities including the development, review, and generation of queries and query tracking.

• Perform Data Management activities and support to internal and external project teams.

1) Do you have a recent CRO industry experience?

3) Do you have 7+ years of hands-on experience as a CDM?

• Previous CRO experience is strongly recommended.

• Client-facing experience is preferred, but not required.

• Excellent oral and written communication skills.

Multiple years’ CDM or other data analytics / data management experience, including experience leading small projects and project teams.

Acts as a point of contact for study management teams and for Clinical Development regarding data management issues.

Ensures adherence to standard business processes within CDM systems to assure compliance with regulatory requirements.

Trains and mentors less experienced in colleagues in CDM processes, projects, programs and tools.

Adheres to regulatory requirements, industry standards and Gilead SOPs and ensures the same across own team.

Demonstrates strong facilitation / presentation skills and ability to appropriately delegate tasks to others.

You will Oversee (and sometimes lead) the data management of Phase 1 through 4 clinical trials in a small development program

Represent Data Management on the Development Core Team and/or Clinical Trial Working Groups as appropriate

Provide direction and leadership in CRO and vendor selection and management.

Be responsible for and manage data management activity of Clinical Data Managers assigned to his/her trials

Coordinate closely with Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Drug Safety, Project Management, and Regulatory to ensure operational excellence.

Contribute to strategic planning to ensure optimized use of data management resources within the area of responsibility

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

Data Management experience in clinical trials

Oversee the data management procedures and designs for clinical trials

Support sponsor interaction activities from a data management perspective

Study start-up, study conduct, and study close-out experience

Interact cross-functionally to design and validate specification and edit checks for EDC systems

Assisting with studies within a TA from SSU to DBL

Allocate and prioritize workloads for multiple projects (media control, data entry, pre entry review and query management tasks)

Competent working knowledge of clinical trials and the clinical data management role in the clinical trials process

Excellent organizational and project management skills

Technical skills including EDC systems, clinical data management systems, Microsoft Office

Serve as a primary or backup resource for issues pertaining to data management

Assist other Clinical Data Managers or Project Managers with management of timelines and budgets as they pertaining to data management activities

Development and maintenance of data management documents (such as laboratory data management plan, Data Query Plan, and Data Transfer Agreements (DTAs))

Bachelor’s degree in life sciences or other relevant discipline, or equivalent domain experience required.

Good organization and planning skills.

Strong interpersonal skills and communication skills (both written and oral).

Strong leadership skills, self-motivated, adaptable to a dynamic and fast paced environment.

Weekly sample status metrics and/or any other study specific metrics and reports

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.

Experience using EMR and strong computer skills preferred.

You will maintain working knowledge of protocols and eCRF completion guidelines for assigned projects.

You will regularly review protocol, amendments or clarifications, and revisions for eDC data entry.

You will support non-treatment studies. You will abstract and analyze data from necessary sources to complete the EDC and resolve queries.

A strong understanding of research protocols and implementation.

Attention to details and accuracy

Develop and review data management procedures for clinical trials with sponsor companies and other departments;

Design reports and metrics that are useful management tools for your projects;

Attend and participate in teleconferences and face-to-face meetings with sponsor companies as the lead representative from data management;

May provide project data management training as needed regarding CRF Completion or EDC system usage;

Coordinate overall data management by serving as primary contact for the sponsor, external data providers, and all project team members

Manage multiple projects and associated project team members; and

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.