Remote Site Monitor Central (Sofia, Bulgaria)

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 trulycollaborative and winning culture as we strive to bend the time and cost curve of deliveringlife-saving therapies to patients.

Currently, we are looking to expand our team and we have 3 open positions for Remote Site Monitor – Central

The role

RSM-Central 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. In addition, reviews study data from various sources remotely. They develop collaborative relationships with investigational sites and other stakeholders as applicable. They also contact the study sites to collect study documentation, resolve issues and request outstanding information if applicable.

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.

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 trulycollaborative and winning culture as we strive to bend the time and cost curve of deliveringlife-saving therapies to patients.

Currently, we are looking to expand our team and we have 3 open positions for Remote Site Monitor – Central

The role

RSM-Central 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. In addition, reviews study data from various sources remotely. They develop collaborative relationships with investigational sites and other stakeholders as applicable. They also contact the study sites to collect study documentation, resolve issues and request outstanding information if applicable.

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.Requirements

Does this seem interesting for you? If yes, please, check what the role requires for you to have:

Education and Experience:

· Bachelor's degree in life science-related field

· Prior clinical research experience 0-1 year as well as knowledge of clinical monitoring that provides the required knowledge skills and abilities (For instance, previous experience in a clinical environment where experience is gained in clinical trials, data management, medical terminology, medical research or health care)

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

· 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

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.

- 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.

Requirements

Does this seem interesting for you? If yes, please, check what the role requires for you to have:

Education and Experience:

· Bachelor's degree in life science-related field

· Prior clinical research experience 0-1 year as well as knowledge of clinical monitoring that provides the required knowledge skills and abilities (For instance, previous experience in a clinical environment where experience is gained in clinical trials, data management, medical terminology, medical research or health care)

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

· 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

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.

- 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.