We believe that an inclusive and respectful workplace culture fosters a sense of belonging among our employees, builds a stronger team, and allows individual employees the opportunity to maximize their personal potential IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
We endeavour to keep your personal information secure with appropriate level of security and keep for as long as we need it for legitimate business or legal reasons.
Responsibilities: checking and formatting documents (including drafting complaint handling responses, documents and memos; document and file management, including all litigation documents monitoring internal and external deadlines; monitoring functional mailboxes; Monitoring caselaw, where relevant for the activities of the Legal Unit Support Data Protection Officer in personal data documentation Requirements: A post-secondary education attested by a diploma in law. Excellent knowledge of MS Office tools, in particular Word, Excel, and AI tools Excellent written and spoken English skills Strong coordination and communication skills What we offer: A interim (6-months plus possibility to prolong) employment contract according to the DGB/GVP collective agreement Above-average compensation, plus holiday and Christmas bonuses An interesting position that matches your qualifications, with the possibility of permanent employment by the client company Your path to us: If you would like to apply directly, you are welcome to send us your CV by email or submit your information via the online application form.
Kontinuierliche Entwicklungs- und Fördergespräche sind unser Versprechen an Sie Wir betreuen und unterstützen unsere Mitarbeiter stets durch einen persönlichen Ansprechpartner aus unserem Personal-Team Wir bieten spannende und herausfordernde Projekte aus der ganzen Welt des Engineerings, der IT und allen Schnittstellen im Bereich Business Administration – in den größten Industriezweigen Deutschlands matchING ist Tarifpartner des BAP.
Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in Sponsor clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head.Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant Sponsor SOPs and local regulations.Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with Sponsor SOPs.Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.Reviews monitoring visit reports (as required and following Sponsor SOPs) and pro-actively advices the monitor(s) on study related matters.Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.Proactively identifies risks and facilitates resolution of complex study problems and issues.Organises regular Local Study Team meetings on an agenda driven basis.Actively works towards achieving good personal relationships with all Local Study Team members, sites’ staff and global stakeholders.Reports study progress/update to the Global Study Associate Director/ Global Study Team including SMM Lead.Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.Develops, maintains and reviews risk management plan on country study level: proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.Plans and leads National Investigator meet Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA.Provides input to process development and improvement.Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues.Updates Line Managers about the performance of the CRAs/CSAs.Ensures that study activities at country level comply with local policies and code of ethics.Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.Ensures compliance with Sponsor´s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).Collaborates with local Medical Affairs team.Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.
We endeavour to keep your personal information secure with appropriate level of security and keep for as long as we need it for legitimate business or legal reasons.
We endeavour to keep your personal information secure with appropriate level of security and keep for as long as we need it for legitimate business or legal reasons.
We endeavour to keep your personal information secure with appropriate level of security and keep for as long as we need it for legitimate business or legal reasons.
We endeavour to keep your personal information secure with appropriate level of security and keep for as long as we need it for legitimate business or legal reasons.
We endeavour to keep your personal information secure with appropriate level of security and keep for as long as we need it for legitimate business or legal reasons.
We endeavour to keep your personal information secure with appropriate level of security and keep for as long as we need it for legitimate business or legal reasons.
We endeavour to keep your personal information secure with appropriate level of security and keep for as long as we need it for legitimate business or legal reasons.
We endeavour to keep your personal information secure with appropriate level of security and keep for as long as we need it for legitimate business or legal reasons.
We endeavour to keep your personal information secure with appropriate level of security and keep for as long as we need it for legitimate business or legal reasons.
We endeavour to keep your personal information secure with appropriate level of security and keep for as long as we need it for legitimate business or legal reasons.
We endeavour to keep your personal information secure with appropriate level of security and keep for as long as we need it for legitimate business or legal reasons.
We endeavour to keep your personal information secure with appropriate level of security and keep for as long as we need it for legitimate business or legal reasons.