(Senior) Clinical Research Manager (m/f)
Office based near Munich, Germany
Full-time (1 FTE)
inVentiv Health Clinical are currently recruiting for dedicated and motivated Clinical Research Managers (Clinical Project Managers) with previous clinical research experience in Germany to work Office Based near Munich. You will be working on studies for a global Pharmaceutical client, playing an integral role within an established team.
inVentiv Health: Work Here. Matters Everywhere.
This is a great opportunity for someone looking to work on oncology, neurology and cardiology studies from Phase II-III as a sponsor-based Clinical Research Manager (CRM).
At the Country Operations level, the CRM has a significant impact on the ability to effectively conduct clinical studies and develop the pipeline, while maintaining local regulatory and compliance requirements.
The CRM has a significant impact on how a country can deliver country-specific trial commitments and objectives. As a customer-facing role, this position will build business relationships and represent the sponsor with investigators, functional outsourcing partners and other external partners and therefore have a significant impact on country-level customer relationships.
The position requires the ability to make decisions independently and oversee important activities relevant to clinical research activities in the country according to predetermined global policies and commitments with the support, oversight and supervision of the Country Research Director. Requires strong understanding of local regulatory environment for the individual to weigh pros and cons of key decisions with input from manager.
* The incumbent is accountable for the performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, SPONSOR policies and procedures, quality standards and adverse event reporting requirements internally and externally.
* The CRM is the country point of contact (POC) for assigned protocols between ROC and CO and pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments, requiring strong collaboration with local Country Operations roles. The CRM forecasts country resource needs and serves local business needs (signs contracts, manages budgets as delegated).
* The CRM is responsible for quality and compliance for assigned protocols in the country and oversees CRAs and/or CTCs and training compliance. Performs quality control visits, reviews Monitoring Visit Reports and escalates performance issues and training needs to functional vendor and internal management as needed.
* The CRM is responsible for collaboration and relationship management with investigators for insourced and outsourced studies, with functional outsourcing vendors and other external partners. The CRM oversees country and site validations, site selection and recruitment in assigned protocols.
* The CRM is responsible for clinical trial education to sites, and acts as the country POC for programmatically outsourced trials for assigned protocols. In collaboration with CRD, represents Sponsor/SPONSOR in Pharma industry issues and in seeking influence in external R&D environment.
* The CRM collaborates internally with GMA/GHH, local PV and Regulatory Affairs to align on key decisions in countries. Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations. The position requires coordination and alignment with the regional and broader organization.
* The ability to identify problems, conflicts and opportunities early and lead, analyse and prepare mitigation plans and drive conflict resolution is critical. The position requires skilful negotiation in tough situations with both internal and external groups; settle differences with minimum noise; win concessions without damaging relationships; be direct and forceful as well as diplomatic; gain trust quickly from other parties in negotiations and have an excellent sense of timing.
To apply for this position you must have previously worked in as a Clinical Project Manager in Germany (at least one year experience), hold an EU passport or valid German work visa, speak fluent German and English and be willing to work office-based in Germany.
* Major studies: Minimum Bachelor's degree, desire Master of Science or Medicine (or comparable). Advanced degree (PhD) possible but not required.
* 8-10 years of clinical research experience for a BS/MS/MBA/JD; 3-6 years for an MD-PhD
* Strong understanding of clinical trial planning, (site)management and metrics
* Strong communication, educational/pedagogic, diplomatic and empathic skills.
* Strong leadership skills (scientific and business) and proven ability to coordinate and lead local teams to high performance.
* Strong organizational skills with demonstrated success required.
* Ability to lead across several dimensions simultaneously.
* Excellent oral and written English language skills.
* Problem solving and conflict resolution
* Negotiation skills with both internal and external groups
There are many benefits available to employees of inVentiv. They include highly competitive compensation and benefits including: 30 days annual leave, life insurance, accidental death and disability cover and bonuses! The position is offered through a contract of employment with inVentiv Health Clinical.
If you have the required experience for this position and are eligible to work in Germany then please apply or contact Andreas Schulz on +49 (0)30 345 069 11.
If this role is not suitable for your experience but you have worked in clinical research in the industry and would like to discuss other roles, please contact a member of the inVentiv Health Clinical team on +49 (0)30 345 069 11.
To find out more about our company and search and apply for other open jobs please visit our website http://www.inVentivHealthclinical.com
inVentiv Health is a global professional services organization designed to help the biopharmaceutical industry accelerate the delivery of much-needed therapies to market. Our combined Clinical Research Organization (CRO) and Contract Commercial Organization (CCO) offer a differentiated suite of services, processes and integrated solutions that improve client performance. With more than 15,000 employees and the ability to support clients in more than 90 countries, our global scale and deep therapeutic expertise enable inVentiv to help clients successfully navigate an increasingly complex environment.