Description:
TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible resourcing solutions, is currently searching for a Project Manager Associate to work with one of our partner Medical Device Companies.

As this is a client-facing role, we are looking for confident candidates with strong management skills and the ability to work independently whilst establishing a high-trust environment with the client counterparts.

Scope of the role:

• Under limited supervision, involved and assist with the management of the clinical studies in accordance with the applicable domestic and international government regulations, Clinical Investigation Plans, and Standard Operating Procedures
• Assist with the development of effective clinical trial strategies, preliminary project timelines, and budgets for clinical project(s) to ensure successful product development and worldwide marketing efforts. Included are assisting with the study design, coordinating, managing, and working with clinical support resources such as clinical research monitors/clinical research associates, Field Clinical Engineers, and CROs
• Provide clinical support to Sales and Marketing Departments as required
• Work closely with Clinical Management to recommend and implement improved methods by developing and/or modifying department procedures, systems, and in-house training that ensure compliance with regulatory requirements

Job specific tasks and responsibilities:

Clinical Management

• Coordinate project team meetings
• Assist Clinical Management with the development of clinical study strategies
• Provide input to the study design and protocol development
• Prepare, review, and distribute study plans, study agreements, informed consent forms, and other study materials
• Assist with and coordinate preparation of regulatory applications, amendments, questions from the authorities, supplements, reports, and advisory panel presentations needed to conduct studies and approve products
• Assist and drive clinical site selection
• Establish and maintain first-line contact with investigators and site staff
• Oversee and provide clinical input for the design of the Case Report Forms and electronic databases
• Prepare and give clinical presentations to physicians, clinical study staff, agents, and distributors, as required
• Reviews and verifies adequacy of site activation documentation
• Assure clinical studies are adequately managed to meet the protocol objectives and schedules
• If applicable, support Data Monitoring Committees (also called Data Safety Monitoring Boards) and other committees/consultants established to support the studies
• Assist data management staff with clinical data review and collection of data from sites. Assists and oversees study compliance/safety including data integrity: protocol deviations, adverse events, issues, etc. If applicable, collaborates with the biometrics team to implement risk based study management
• Helps to ensure sponsor and site compliance to domestic and international government regulations
• Communicate regarding the study with the client and participating sites on issues, questions, and study updates
• Assist with clinical study site monitoring, as necessary and review of monitoring activity/reports
• Takes initiative to oversee activities of Contract Research Organizations (CROs), if applicable
• Create, update, and maintain site administrative files and trial master files (electronic and/or paper)
• Maintain accurate and up-to date study tracking documents (eg enrolment, regulatory approvals and renewals, payments) and systems (eg CTMS)
• For premarket studies, instruct warehouse and field staff in clinical device distribution and recovery. Maintain device accountability report
• Coordinates and assists biometrics with the data review, analysis and preparation of the study reports and coordinates their deliveries
• Coordinates closeout of sites/study, archive study documents

Project Management:

• Manages the delivery of study requirements to the protocol, the site needs, and the required timelines set for the project
• Applies principles, concepts and techniques for effective project management of a clinical study
• Establishes priorities among activities
• Tracks and measures project variances
• Provide input for clinical study budget and project plans
• Seeks input from higher-level clinical experts or program management as issues warrant
• Work with Clinical Management to recommend and implement methods for improving processes and addressing issues within the clinical research department
• Understand and take lead in explaining issues and defining possible responses/ solutions/ alternative approaches

Education and Experience:

• Minimum Bachelors / Master's Degree in a scientific discipline; biomedical or related fields is preferred
• Minimum prior work experience of 4+ years as a Clinical Research Associate or comparable position assisting/supporting clinical project management at a medical device/drug company/CRO
• Experience as a Project Coordinator/Manager is advantageous
• Experience in working in an international environment is a plus

Skills:

• Knowledge of international regulations and guidelines (ISO14155/GCP), and clinical study design and implementation.
• Working knowledge of medical terminology
• Capability and willingness to learn device function
• Ability to interface effectively with medical professionals
• Strong analytical and organization skills
• Project tracking capability
• Good oral and written communication skills
• Excellent attention to detail and accuracy
• Good presentation skills
• Experience with electronic data capture (EDC) and clinical trial management systems (CTMS)
• Demonstrated ability to perform in a team environment
• Proficient with MS Office Suite
• Ability to travel as necessary to clinical centers to establish and manage clinical studies. Able to travel at a minimum of 25%.
• Fluency in English language (writing and speaking), additional language(s) advantageous

Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

About TalentSource Life Sciences

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002543

or please contact Rocio.EgeaMota@cromsource.com for more information.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: Project Manager Associate
Skills: Associate Project Manager, ICH-GCP, MS Office, Project Management, Regulatory Location: Belgium Share:

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