Remote Site Monitor - Central

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

We are currently looking to hire:

Remote Site Monitor – Central, Bulgaria

The RSM-C will work highly independently and perform critical assessments to determine best approaches to automate subject data using multiple pathways and systems. The expert should be capable of leading active and challenging interdepartmental discussions to explore best strategies and practices after understanding trial specific needs and diverse data bases that can be used as source of information.

Major responsibilities:

• Reviews subject data from multiple sources with a data analytic mindset, capable of identifying trends, risks, gaps and areas for optimization as the subject data and the trial develops.
• Prepares and analyzes clinical trial patient datasets, such as laboratory data, vital signs data, tumor response data, imaging data, quality of life and well-being questionnaire data, or adverse events data, for clinical research purposes.
• Uses and develops tools and applications to provide the outputs or to validate outputs for clinical use.
• Adapts to constant changes as trial develops and multiple factors and inputs developed by internal or external stakeholders impact subject data.
• Capable of providing concise and clear updates to study teams and other key stakeholders after processing and reviewing subject data.
• Continually makes efforts to increase knowledge base and professional skills in areas such as programming, technology and techniques, clinical trials, and the pharmaceutical industry by working closely with mentors, attending presentation / teaching events, and contributing to other general department documents and policies by assisting mentors with implementing best practice documents and articles.
• Reviews and clarifies key aspects with stakeholders from multiple departments to obtain a proper understanding of protocols, site contracts and budgets, eCRFs and other electronic data sources, systems setup and structure, in order to define strategies and propose solution to automate subject data.
• The RSM-Central has thorough understanding of protocol schedule of events (visits, activities and procedures), Contracts, budgets and payment terms to define data points in electronic data systems to automatize subject creation, visit tracking and activities tracking responsible to trigger site payments. 
• Escalates performance issues to clinical, site payments and IT managers and may assist with resolution (Follows Escalation Pathway as applicable). Lead internal team meetings and provide updates on subject data statuses. Manage escalations (project team, site and sponsor) regarding tracking system setup/maintenance issues. 
• As a subject data analyst and expert of subject data behavior, the RSM-C needs to be capable of performing manual adjustments as needed without compromising data integrity and with little guidance for decision making. Assists with additional activities dependent on subject data integrity and flow which impact downstream processes such as invoice discrepancies, overall subject data trends and queries, data correction and its impact on dependencies.
• Assists in ensuring audit ready files and complying with CTMS and eTMF data stewardship. Contributes to company, client, and federal/local regulatory requirements/audit responses. 

Qualifications and Skills:

Education and experience:

• Bachelor's degree in life science-related fields, Engineering, Biostatistics and/or Programing.
• Prior clinical research experience of minimum 3 years and/or knowledge of clinical trials and subject study events.
• Prior experience of minimum 3 years on process development, process improvement; data assessments, analytics and critical assessments.

Knowledge, skills and abilities:

• Highly independent and capable of leading multidisciplinary discussions as needed.
• Comfortable with decision making and proper documentation practices.
• Capable of working under continuous pressure and continuous changing challenges adapting to new priorities and needs as they arise.
• Experience with Siebel CTMS and/or multiple data bases with scientific background.

• Proven understanding of relational data base structure and complex data systems
• Proven understanding and use of Microsoft Excel 
• Capable of effectively capturing and reviewing data
• Capable of providing quality control support 
• Good attention to detail
• Good problem-solving skills
• Excellent written and verbal communications skills to effectively interface with teams and clients, including proficiency in the English language
• Capable of effectively organizing and managing multiple assignments with challenging timelines
• Capable of adapting and adjusting to changing priorities
• Positive attitude and the ability to work well with others
• Demonstrate initiative and self-motivation

What we offer:

At PPD Clinical Research Services we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.  

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD Clinical Research Services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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