PPDis a leading global contract research organization providing comprehensive,integrated drug development, laboratory and lifecycle management services. Ourclients and partners include pharmaceutical, biotechnology, medical device,academic and government organizations. With offices in 48 countries and morethan 21,000 professionals worldwide, PPD applies innovative technologies,therapeutic expertise and a firm commitment to quality to help clients andpartners bend the cost and time curve of drug development and optimize value indelivering life-changing therapies to improve health.
Accountable forachieving the final clinical deliverable (usually clean data from evaluablepatients as specified in the study protocol) within the time period specifiedin the contract with the customer. Interprets data on project issues and makesgood business decisions with support from experienced team members or linemanager. Works to ensure that all clinical deliverables meet the customer'stime/quality/cost expectations. Maintains profitability by ensuring clinicalactivity is conducted within contract scope, through efficient management ofthe clinical team. Typically works on projects of low to moderate complexityand as part of a team of CTMs. Please note this position will be office-basedat the client's office in Zeist.
·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.
- 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 preferred
- 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 & Dutch
- 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.
PPD is an EqualOpportunity Employer.
Please note that onlyshort-listed candidates will be contacted.
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