Clinical Study Manager Client-dedicated Amersfoort
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 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.
Responsibilities include but are not limited to :
Manages all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP.
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 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.
Education and Experience :
Degree in pharmacy, life science or related field
Clinical Study Management expeirence
Fluency in English and Dutch
Knowledge, Skills and Abilities :
Demonstrated understanding of medical / therapeutic area knowledge and medical terminology
Excellent understanding and demonstrated application of GCPs and applicable SOPs
Management of regulatory and / or IEC questions
Development and preparation of the local informed consent form
Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
Management of the delivery of study supplies
Strong customer focus
Effective interpersonal skills
Strong attention to detail
Effective organizational and time management skills
Proven flexibility and adaptability
Ability to work in a team or independently as required
Good computer skills : good knowledge of Microsoft Office and the ability to learn appropriate software
Good presentation 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.
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.