Clinical Study Manager - client-dedicated, Warsaw

Submission for the position: Clinical Study Manager - client-dedicated, Warsaw - (Job Number: 172102)

Clinical Study Manager – Client-dedicated – Warsaw

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.

Our team is expanding, and we are looking to recruit a CSM to be dedicated to one client only, using and working with their systems, SOPs and monitoring only client’s studies.

Essential Functions:

·Manages all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects.

·Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.

·Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained.

·Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.

·Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitors or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.

·May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.

·May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensures that essential document quality meets the expectation of Regulatory Compliance Review. Reviews and follows up on all questions raised by the ethics committees. ·May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.

Clinical Study Manager – Client-dedicated – Warsaw

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.

Our team is expanding, and we are looking to recruit a CSM to be dedicated to one client only, using and working with their systems, SOPs and monitoring only client’s studies.

Essential Functions:

·Manages all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects.

·Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.

·Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained.

·Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.

·Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitors or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.

·May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.

·May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensures that essential document quality meets the expectation of Regulatory Compliance Review. Reviews and follows up on all questions raised by the ethics committees. ·May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.

Qualifications:

Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Clinical research experience combined with around 1 year of CTM experience Preference for local (instead of international) experience Therapeutic area knowledge: Oncology is a must In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role – i.e. previous experience of leading a team and/or projects

Knowledge, Skills and Abilities: Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams Good planning and organizational skills to enable effective prioritization of workload Solid interpersonal and problem-solving skills to enable working in a multicultural matrix organization Capable of working effectively in a changing environment with complex/ambiguous situations Familiarity with the practices, processes, and requirements of clinical monitoring Good judgment and decision-making skills Effective oral and written communication skills, including fluency in English & Polish Capable of evaluating workload against project budget and adjusting resources accordingly Sound financial acumen and knowledge of budgeting, forecasting and fiscal management Strong attention to detail Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc. Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.

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.

- 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.

Please note that due to the high volume of applications, only short-listed candidates will be contacted.

PPD is an equal employer.

*LI-MP1

Qualifications:

Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Clinical research experience combined with around 1 year of CTM experience Preference for local (instead of international) experience Therapeutic area knowledge: Oncology is a must In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role – i.e. previous experience of leading a team and/or projects

Knowledge, Skills and Abilities: Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams Good planning and organizational skills to enable effective prioritization of workload Solid interpersonal and problem-solving skills to enable working in a multicultural matrix organization Capable of working effectively in a changing environment with complex/ambiguous situations Familiarity with the practices, processes, and requirements of clinical monitoring Good judgment and decision-making skills Effective oral and written communication skills, including fluency in English & Polish Capable of evaluating workload against project budget and adjusting resources accordingly Sound financial acumen and knowledge of budgeting, forecasting and fiscal management Strong attention to detail Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc. Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.

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.

- 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.

Please note that due to the high volume of applications, only short-listed candidates will be contacted.

PPD is an equal employer.

*LI-MP1

Submission for the position: Clinical Study Manager - client-dedicated, Warsaw - (Job Number: 172102)