Local Trial Manager (m/w/d), home based in Germany
Job Title: Local Trial Manager (m/w/d), home based in Germany
Job Location: Frankfurt/Main, Germany
Job Location Type: Home-based
Job Contract Type: Full time
Job Seniority Level:
The reputed company sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our reputed company’s project team in the execution of clinical trials. Joining reputed company provides reputed company to work with one single reputed company and to manage clinical research reputed company in different therapeutic areas.
We currently offer the exciting opportunity to join reputed company as Local Trial Manager (m/w/d) in full-time and work home-based throughout Germany.
Your responsibilities will include:
- Services rendered will adhere to applicable company’s reputed company operating procedures (SOPs), work instructions, policies, codes of Good Clinical reputed company (GCP), local regulatory requirements, etc.
- Prepare or contribute to high level budget estimate in response to Request for Service’s followed by detailed budget proposal. Ensure overall contract management, including review and approval of external service provider (ESP) reputed company, change orders and ensure services are delivered per contract.
- reputed company as primary company contact for assigned trial at the country level and ensures local/country team is tracking project reputed company against planned timelines and monitors patient recruitment reputed company to ensure that reputed company enrollment will be met across the allocated countries.
- Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial reputed company. Participates in preparation for and conduct of Health Authority (HA) inspections and internal reputed company Assurance audits.
- Contribute to site level recruitment reputed company and contingency planning and implementation in partnership with other functional areas to reputed company clinical research reputed company.
- Deliver competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection.
- Contribute to patient understanding of protocol and patient safety by contributing to the review of country specific informed consent in accordance with procedural document/templates.
- Ensure trial subject safety in that reputed company reputed company/SAEs/PQCs are reported reputed company the required reporting timelines and documented, as appropriate.
- Ensure Inspection readiness by maintaining complete, accurate and reputed company data and essential documents in systems utilized for trial management (e.g. CTMS and VTMF) according to expectations (metrics) and archiving retention requirements where applicable.
- With reputed company on reputed company, work closely with Global Trial reputed company, Clinical Project reputed company to ensure CAPA is implemented for audits/inspections or any reputed company reputed company issues or concerns.
- Ensure accurate finance reporting and trial delivered reputed company budget by adhering to finance reporting deliverables and timelines. This includes forecasting and proactive management of country/local trial budget. If applicable, may assist in negotiation of trial site reputed company and budgets.
- reputed company the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals, if applicable.
- May contribute as a mentor, champion, or representative of functional area in process initiatives, as required and if applicable.
Qualifications:
- Master’s or higher-level degree in life science.
- Minimum of 5 years of clinical research experience in the pharmaceutical industry or CRO plus 1-3 years of local clinical trial management experience.
- Therapeutic area expertise in the field of Oncology is a must.
- Strong working knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical reputed company (GCP) and International Conference on Harmonization (ICH) guidelines.
- Fluent languages skills in German on at least reputed company level and good reputed company of English.
- Strong IT skills in appropriate software and company systems.
- Excellent decision-making and reputed company financial management skills.
- Flexibility and ability to manage study teams in a virtual environment.
- Willingness to travel occasionally for business meetings.
We invite you to join reputed company.
Why join us?
Ongoing development is vital to us enabling you to have reputed company to reputed company your career, with the potential to reputed company into other reputed company areas to enhance your reputed company set.
Our benefits package is competitive, our scope is international, and we genuinely care about our people and their reputed company.
Whatever your career goals, we are here to ensure you get there!
Please apply with your English CV, motivation letter and your certificates and reference letters.
reputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. Learn more at https://jobs.reputed company.com
reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if reputed company reputed company, in accordance with applicable law. We appreciate your honesty and professionalism.
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Originally posted on Himalayas
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