• Provides oversight and coordination of study initiation. Reviews, interprets, translates and programs study protocols into a complete and accurate database. Communicates with internal departments and external vendors and ensure the project requirements are understood, agreed and followed at all times. Facilitates the flow of technical and clinical laboratory information to all stakeholders (investigational sites, sponsors, and non-technical personnel). Consults and utilizes, where appropriate, the scientific input of laboratory management and technical staff to assist the client with management of the clinical trial.
• Prepares the study specifications documents and follows the preparation according to budgets and contracts. Maintains at all times an updated study master file with version controls for specs, budgets and contracts. Ensures sponsors have authorized and signed off most recent versions of all docs and that a contract exists prior to deliver any services. Assures compliance with FDA and Good Clinical Practice guidelines, PPD SOP’s, personnel policies and procedures, PPD Exposure Control Plan, IATA, and other regulations regarding the transport of biological specimens.
• During initial review of protocol, consults with internal groups and support staff regarding procedural and budgetary items and the necessity for change due to any subsequent protocol amendments. Obtains other functions’ commitment to close gaps and address issues timely and effectively. Serves as chief liaison between sponsor and all PPD internal departments performing the required tasks during all study phases. Educates Investigator sites by delivering a protocol specific lab procedures presentation and demonstration during an investigator meeting. Controls, manages and follows day to day activities during the course of the clinical trial to resolve any issues and answer queries
• Actively consults with IT and data management development groups in the design, validation and implementation of new software and functionalities pertinent to project management activities.
• Consults with BD and finance staff during initial project documentation review on standard services and costs, supporting RFP feasibility assessments. Advises on possible solutions if needed. Drafts responses for proposals.
• Guides and supports work flow of Projects Managers and Set-up Administrators with special attention to training junior personnel. Performs as a mentor and trainer for (newly assigned) Project Managers, identifies areas for development and efficiencies in performing tasks. Authors, reviews, revises and implements relevant procedural documents. Serves as a back-up for the (Associate) Director PM, when needed.

• Strong verbal, written and presentation skills
• Superior time management, planning, and organizational skills
• Competent with specific computers and enterprise applications, including office productivity
• Ability to program the IT system according to protocol requirements
• Proven analytical skills
• Demonstrated compliance with procedures and policies
• Ability to perform multiple tasks effectively in a stressful environment
• Extensive knowledge and experience in Project Management in Global Central Lab environment
• Strong client relationship management skills
• Ability to work effectively with multi-level teams

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.
Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.

Currently, we are looking for a Remote Site Monitor in Belgium.
As a Remote Site Monitor, you will perform remote site management and monitoring activities on assigned project(s) in accordance with FDA and/or local regulations and guidelines, ICH GCPs and PPD procedural documents by reviewing study data from various sources remotely. You will contact study sites to collect study documentation, resolve issues and request outstanding information.
About the role:
Performs site management and other related activities on assigned project(s) in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and PPD SOPs. Reviews study data from various sources remotely. Develops collaborative relationships with investigational sites and other stakeholders as applicable. May contact the study sites to collect study documentation, resolves issues and requests outstanding information if applicable. Detailed tasks and responsibilities assigned to RSM-Central or RSM-Local positions are outlined in the task matrix.
Essential Functions:

• According to the specific role (Central or Local) may coordinate, oversee and complete assigned trial activities detailed on the task matrix, including but not limited to the following:
• Develops and maintains a close and collaborative communication with the site staff. Actively discusses protocol conduction, enrollment rates and strategies, open issues, EDC completion and queries, as well as any other topic or indicator associated to project status and site performance.
• Completes/tracks/follows up ETRTR for subject data present in the EDC and other applicable systems, according to the study-specific guidelines. Raises manual queries in EDC when applicable.
• Remotely reviews study logs as deemed necessary.
• Conducts and documents site management calls/contacts according to the monitoring plan. Participates in investigator meetings. Investigates and follows-up on centralized monitoring findings.
• Evaluates PI oversight (e.g., protocol adherence), subject safety and study processes to assess site’s ability to conduct study on a regular basis. Conducts remote investigations into site performance using a risk based monitoring approach: applying root cause analysis (RCA), critical thinking and problem-solving skills to help identify site process failure and work on corrective/preventive actions to bring the site into compliance and decrease risk.
• Provides refresher training, follows up on outstanding administrative needs (e.g., outstanding/updated regulatory documents), assists with regulatory reviews, as requested, etc.
• Reviews ad-hoc clinical listings review, tracks and trends violations and deviations, site status, enrollment, CRF status and SAE follow up.
• Provides trial status tracking and progress update reports to study manager.
• Participates in the investigator payment process, if applicable.
• Liaises with internal staff to promptly collect documents, review data points and findings from EDC and file reviews, etc.
• 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.
• Detailed task assignment and responsibilities are outlined on the task matrix, as well as any applicable protocol guidelines.

Education and Experience:

• Bachelor’s Degree in a life science-related field OR Registered Nurse license along with an Associate’s Degree in Nursing.
• Prior clinical research experience 0-1 year as well as knowledge of clinical monitoring through classwork/training that provides the required knowledge skills and abilities.
• In some cases, previous experience in a clinical environment where experience is gained in clinical trials, data management, medical terminology, medical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.
• Prefer individuals who aspire to advance into a CRA role.

Knowledge, Skills and Abilities:

• Basic medical/therapeutic area knowledge and understanding of medical terminology
• Ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and PPD procedural documents
• Ability to successfully complete PPD’s Clinical Foundation Training Program (CFP)
• Ability to successfully complete the RSM Onboarding Workshop
• Ability to evaluate medical research data
• Ability to advise, counsel, and motivate investigational sites
• Effective oral and written communication skills with the ability to communicate effectively with medical personnel
• Excellent interpersonal and customer service skills
• Good organizational and time management skills
• Proven flexibility and adaptability
• Strong attention to detail
• Ability to work in a team or independently, as required
• Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
• Ability to coach and mentor site personnel.
• Good computer skills with good knowledge of MS Office ability to learn and use appropriate software. Leverage modern technology when applicable.
• Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards
• Excellent English language and grammar skills

What we offer

At PPD 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 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.

PPD Defining Principles:
- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD –

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.

#LI-SG1

BE BUBE-BE-Brussels-Brussels BE St Stevens Woluwefalse828682truefalse