Clinical Trial Management Associate Jobs

Experience, Education And Specialized Knowledge And Skills

Responsible for data entry and status updates within the Ipsen Clinical Trial Management System (CTMS)

Ability to work in a strong regulated environment within a quality management system (QMS)

Manage the clinical study creation and set-up for the country and site binders and the trial milestones.

Experience in clinical study environment within CRO or Pharmaceutical company.

Minimum: Knowledge of the clinical study environment with a strong theorical or practical administrative organization.

· SAP software based computer systems experience.

· MS Office and MS Teams experience.

·SKYPE Meeting or Virtual Meeting software experience.

·GMP and Pharmaceutical Industry Regulations knowledge.

Job Title:Clinical Trial Supply Chain Specialist

·Additional services provided include Product Complaint evaluation, classification, and notification, temperature excursion evaluation and processing.

Conducts study tracking (e.g., CTMS, start-up, milestone, close-out); generates, reviews and distributes management reports from internal tracking systems at requested intervals

Assists with the tracking and management of study specific budgets

Assists with facilitating resolution of data queries and requests from Clinical Data Management

Critically evaluates job tasks and the impact on overall trial management objectives

Collaborates with the Clinical Trial Manager and/or the Clinical Project Lead on the development of certain study-specific plans and/or processes

Prepares investigational site reference materials (i.e., screening/enrollment logs, Delegation of Site Responsibilities form, Site Monitoring Log, etc.)

A working knowledge of clinical drug development and clinical operations processes and experience applying GCP, ICH and FDA requirements.

Complete any other task as assigned by direct manager.

Strong communication and organizational skills.

At least 3 years of experience pharmaceutical industry or clinical research site-based experience.

Knowledge of Regulatory and ICH GCP guidelines.

System experience preferably in CTMS, eDC, (e)TMF applications.

· Competitive salary with benefits

· Support US Post-marketing Global Registry and clinical trials activities

· Bachelor degree in Biological Sciences, Nursing, Pharmacy, or related major is preferred

· Understanding of ICH-GCP Guidelines

· High degree of commercial exposure early in your career

· Being a part of team whose work directly aims to improve the quality of people’s lives

Experience with electronic systems (e.g., eTMF, EDC, and other data management software).

Participate in site and vendor selection and qualification.

Experience as a Clinical Research Associate (CRA) highly preferred.

Experience with managing study vendors (e.g., CRO, IRT/IXRS, central laboratories) preferred.

Practical knowledge and implementation of ICH-GCP guidelines and US and ex-US regulations.

Must be organized with excellent oral and written communication skills.

Lab ranges, supporting CRA in range collection and uploading

CTMS updates (site accounts, site contacts, milestones, site ICFs), supporting CRA and SSUs

ICF- customization per site, eTMF upload country and site ICF

Help with revision of documents to be submitted (SSU)

Ad hoc printing and shipping documents to sites

Organizing meeting and taking minutes, when required

Inform the Clinical Operations Manager/Project Team on any outstanding document(s).

Support the Clinical Operations Manager(s) coordinating project meetings, including scheduling and drafting, distribution, and filing of meeting agendas and minutes.

Experience in managing eTMF platforms in an outsourced environment is required, with a minimum of 2 years of experience strongly preferred.

Understanding and working knowledge of regulations and standards applied in clinical areas, medical devices, and/or pharmaceutical products is required.

Strong skills with Microsoft Excel and SharePoint are required.

Communicate effectively with clinical study administration vendors (Functional Service providers etc.).

·Bachelor’s degree (BS/BA) or equivalent combination of education and work experience in science related field

·Familiarity with document filing/management in an electronic Trial Master File preferred

·Manage spreadsheet and input payment terms and amounts for each clinical study/site

·1-2 years Clinical Operations or clinical research-related experience is preferred

·Excellent problem-solving, critical thinking, verbal, and written communication skills

·Ability to manage confidential information with discretion

• Excellent communication, time management and organizational skills

• Work with the clinical operations team to prepare metrics and updates for management

• 2+ years of experience in a clinical operations role in the biopharmaceutical industry

• Experience planning and tracking deliverables and timelines

• Take ownership of assigned responsibilities, with guidance

• Specific experience in Lymphoma or CAR T trials

Ability to work in a fast paced / dynamic team environment and possess time management skills to meet schedules.

Line management experience. Typically has multiple years’ experience managing other people leaders (with indirect reports).

Experience on governance committees and management teams for CROs or other vendors.

Periodic analysis of data and reporting to management and regulatory representatives.

Manages people managers; recruits, hires, mentors, and manages direct reports as required and supports their professional development.

The job is in-person at the Boca Raton office, remote work as necessary.

You are part of the vendor selection and management process where appropriate

You prepare and execute Statement of Work (SOW) with vendor for local drug management

University degree in Health Science, or a related field (an equivalent combination of education, training, and work experience may be considered)

You review, discuss, and communicate packaging and labelling requirements, as defined by the protocol, with vendors

Two years experience in Clinical Research or related industry

Strong social and interpersonal skills (written and oral). You will be confident speaking to Health Care Professionals.

Liaise with Clinical Sample Management for the tracking and coordination of biomarker testing with 3rd party labs

At least 2 years of experience in a clinical research environment

Good verbal and written communication skills

Good organizational skills and attention to detail

Willingness to learn, able to take direction and ability to manage multiple tasks

Maintain clinical trial files (including eTMF), project processes, tracking systems, and other utilized study or departmental systems

Working with vendors and vendor managers to ensure efficient collection of requirements for clinical supply chain functions.

Develop budget overviews based off vendor management, clinical systems and logistics team inputs.

Relevant degree or equivalent education within business or finance area.

Ideally experience working within pharmaceutical or biotech environment, or alternatively working within a supplier or procurement group.

Experience within budgeting and invoice tracking.

Some knowledge of supply chain processes would be advantageous.

Program management experience: ability to prioritize multiple tasks, manage time effectively, and accomplish goals independently and across teams.

Assist in the management of IMP and other study related supplies as needed.

Experience with producing clinical regulatory submissions, e.g., protocols, amendments, safety reports, etc.

Strong communication skills across partners and internal team, including technical writing (e.g. study protocols).

Highly responsive and experienced at building trust and establishing internal and external relationships.

Excellent organizational skills and attention to detail; meticulous follow-through.

Work with accounting/finance to help establish budgets, track invoices, approve vendor activity and assists with budget reconciliation

Train investigative site staff on protocol responsibilities, Investigational Product accountability and study documentation

Excellent written and oral communication and presentation skills

The ability to manage multiple priorities, while maintaining attention to detail is critical.

Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook, and IXRS/EDC platforms)

Specific responsibilities include but are not limited to:

Enter and maintain site information and document tracking in current clinical trial management systems.

Travel Requirements: minimal to no travel if located in Fort Worth; less than 10% if remote

Bachelor’s Degree or Equivalent years of directly related experience (or high school +8 yrs; Assoc.+4 yrs)

Basic knowledge of clinical trial processes

Alcon provides a robust benefits package including health, life, retirement, flexible time off, and much more!

Benefit from working in a highly collaborative and diverse environment, as well as within a welcoming and empowered team.

Ensure compliance with SOPs and regulatory requirements (e.g., GCP and US and OUS guidelines).

Participate in product improvement activities (information gathering, requirements, cross-functional meetings) that meet our customers' needs.

Bachelor's degree or equivalent in a related field with 1-2 years of experience in clinical trials.

Knowledge of digital health solutions and applications preferred.

Knowledge of the clinical research process preferred.

Excellent organization and customer service skills.

Document remote monitoring activities on appropriate report template.

Collect and review essential documents for accuracy and completeness (1572, CVs, medical licenses, etc.) as needed to assist Study Start-up Manager.

Maintain productivity while working remotely.

College degree preferred or equivalent work experience.

Minimum of two years relevant work experience in clinical research operations, ophthalmology highly preferred

Experience working with EDC systems