Clinical Study Manager Client-dedicated Warsaw
We are vital links betweenan 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 andpassion for our purpose : to improve health.
You will be joining atruly collaborative and winning culture as we strive to bend the time andcost curve of delivering life-saving therapies to patients.
Our team is expanding, andwe are looking to recruit a CSM to be dedicated to one client only, using andworking with their systems, SOPs and monitoring only client’s studies.
Essential Functions :
Manages allclinical operational and quality aspects of allocated studies, of low tomoderate complexity, in compliance with ICH GCP.
In accordance to projectspecific requirements, may assume Clinical Study Manager (CSM) responsibilitieson small and / or less complex projects.
Develops clinicaltools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with theData 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 MasterFile (local and central).
May participate in the design and development ofCRFs, CRF guidelines, patient informed consent templates and other protocolspecific documents as required.
Collaborates with the project manager toprepare, organize, and present at client meetings, including bid defense andhand-off meetings.
Collaborates withthe clinical team and other departments as needed to meet deliverables of the project.Regularly communicates with the team and leads team meetings to ensure thattimelines, resources, interactions, and quality are maintained.
Responsible for the implementation and trainingof standardized clinical monitoring processes within the study and according tocorporate standard policies.
Responsible for the timely archiving of documentsand study materials for the department.
Ensuresachievement of the final clinical deliverable within the contractual timeperiod specified by preparing and monitoring clinical activity timelines andmetrics, providing status updates to the project manager, regularly reviewingprojects using tracking and management tools, implementing recovery actions,reviewing monitoring visit reports, and managing CRF collection and queryresolution.
Continuously monitors or co-monitors clinical trials to assessperformance and ensure contractual obligations are met. In smaller regions, mayroutinely conduct Accompanied Field Visits (AFVs) and be accountable for projectfinancials.
May communicatewith study sites regarding issues such as protocol, patient participation, casereport form completion and other study-related issues.
May coordinate allstart-up activities and ensures that timely ethics committee and regulatorysubmissions (if appropriate) are addressed.
Ensures that essential documentquality meets the expectation of Regulatory Compliance Review. Reviews andfollows up on all questions raised by the ethics committees.
May provide inputinto preparation of forecast estimates for clinical activities. Responsible forclinical resource management, assignment, delegation of clinicalresponsibilities and identification of additional resource requirements.
Education andExperience :
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 andAbilities :
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 understandthat you will want to grow both professionally and personally throughout yourcareer, and therefore at PPD you will benefit from an award-winning learningand development programme, ensuring you reach your potential.
As well as being rewardeda competitive salary, we have an extensive benefits package based around thehealth and well-being of our employees.
We have a flexible working culture, where PPDtruly value a work-life balance. We’ve grown sustainably year on yearbut continue to offer a collaborative environment, with teams of colleagueseager to share expertise and have fun together.
We are a globalorganisation but with a local feel.
We have a strong will towin - We earn our customer’s trust - We are gamechangers - We do the rightthing -We are one PPD -
If you resonate with ourfive principles above, and ultimately wish to accelerate the delivery of safeand 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 tothe high volume of applications, only short-listed candidates will becontacted.
PPD is an equal employer.