Observational Research Specialist II - German Speaker

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

We are currently looking for a Observational Research Specialist II to join the team in EMEA. You must be a fluent German speaker and be based in one of the following countries:Croatia - Any Region - Home BasedCzech Republic - Any Region - Home BasedFrance - Any Region - Home BasedHungary - Any Region - Home BasedItaly - Any Region - Home BasedSerbia - Any Region - Home BaseSome travel to Germany will be required.

In this role you will independently provide site management and support activities for Observational/ Non-interventional research study sites in accordance with relevant Standard Operating Procedures (SOPs), study-specific procedures and regulations. Responsible for supporting the development of the Clinical Operations service delivery within Parexel.

Key Accountabilities:Depending on study assignment and with support as necessary key accountabilities can include:Primary contact for assigned sites and build positive business relationships with physicians and site staff.Site identification, selection and start-up activities including negotiation of site agreements and budgets.Customization of country/site specific documentation.Conduct of all remote and on-site monitoring activities through all study stages.Identification of potential out of scope activities.Perform regular reviews of data according to Site Management Plan (SMP).Responsible for the completeness and quality of the site files for the assigned sites.Maintain study management system(s) on a daily basis.

Coordination of a team of ORSs managing a study in a country/ region (language dependent) and main point of contact for the ORL.Regularly inform manager, ORL and PL (as needed) of status of work.Maintain a working knowledge and ensure compliance with applicable Good Pharmacoepidemiology Practices (GPP) guidelines, local country requirements, SOPs and study specific procedures.Coaching and mentoring of new and/ or junior staff members.Assessment of junior staff including shadow/ assessment of calls/ visits as part of ORS Certification activities.Contribution to department service delivery and participation in initiatives.QualificationsKnowledge and Experience:Strong experience with Observational/ Non-interventional research studies.Able to manage study from FEAS to Close out (including Ethics Committee submission and CSA negotiation)Must be a fluent German speakerEducation:Degree in a life science, nursing qualification or other relevant experience requiredSkills:Excellent interpersonal, verbal and written communication skills in English (and local language as necessary).Excellent customer focus and able to interact professionally with a client organization and study site.Strong computer skills, familiar with MS-Office products including Excel, Word and PowerPoint, Clinical Trial Management and EDC systems.Thorough knowledge of Observational/ Non-interventional study research and relevant regulations including GPP.Ability to work in a 'virtual' team environment as well as work independently, seeking guidance as appropriate.Ability to manage complex workload (across multiple studies as necessary) and prioritize accordingly.Consistently delivers work to 'First Time Quality' whilst managing time effectively to meet metrics and/or team objectives.Sound problem solving and analytical skills and able to prioritize multiple tasks and achieve study timelines.Willing to travel locally and internationally as necessary.Seeks opportunities to develop experience and knowledge making suggestions to enhance service delivery.Effectively applies knowledge to provide advice or solutions based on expertise and experience.Ability to provide support and constructive feedback to study team members and Dept. colleagues.