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Munich, Bayern, Deutschland Daiichi Sankyo Europe VollzeitJoin Our Team as a Regulatory Procedural Management and Clinical Trial LeadAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives. With over 120 years of experience and a presence in over 20 countries, we are committed to...
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Munich, Bayern, Deutschland Daiichi Sankyo Europe VollzeitJoin Our Team as a Regulatory Procedural Management and Clinical Trial LeadAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives. With over 120 years of experience and a presence in over 20 countries, we are committed to...
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Munich, Bayern, Deutschland Daiichi Sankyo Europe VollzeitJoin Our Team as a Regulatory Procedural Management and Clinical Trial LeadAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives. With over 120 years of experience and a presence in over 20 countries, we are committed to...
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Munich, Bayern, Deutschland Daiichi Sankyo Europe VollzeitJoin Our Team as a Regulatory Procedural Management and Clinical Trial LeadAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives. With over 120 years of experience and a presence in over 20 countries, we are committed to...
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Clinical Services Engagement Associate, Germany
vor 1 Woche
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Clinical Services Engagement Associate, Germany
vor 2 Wochen
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Lead Clinical Trial Specialist
vor 3 Monaten
Exciting Career Opportunity: Lead Clinical Trial Specialist
Are you driven by a desire to enhance healthcare and make a meaningful difference in patients' lives?
Join our innovative team as a Lead Clinical Trial Specialist (LCTS), where you will be instrumental in assisting biopharmaceutical organizations in navigating the intricate process of clinical trials, ultimately facilitating the delivery of groundbreaking therapies to patients globally.
Location: Hybrid/Remote*
As a LCTS, you will independently manage and oversee clinical investigation sites, proactively address challenges, and ensure that clinical studies comply with established protocols and regulatory standards. You will act as a crucial liaison between project teams and site personnel, ensuring the seamless execution of clinical trials.
Key Responsibilities:
- Establish and uphold quality benchmarks for trial monitoring activities.
- Conduct Selection, Initiation, Monitoring, and Closure Visits at Investigator Sites in alignment with project timelines.
- Oversee clinical study sites to ensure adherence to GCP, ICH, SOPs, and study protocols.
- Supervise the ongoing collection of study data for regular project updates.
- Review necessary regulatory documents.
- Document outcomes from site visits and telephone communications.
- Maintain and update the Clinical Trial Management System (CTMS) in accordance with SOPs and study-specific directives.
- Serve as the Document Owner for collected documents.
- Assist in study start-up processes, including the preparation of Informed Consent forms, development of study documents, and management of site contracts.
- Address site challenges and facilitate communication between project teams and site staff.
- Collaborate with the Centralized Monitoring Team to evaluate risk-based monitoring activities.
- Identify and resolve logistical and practical issues, aiding project teams in formulating solutions and contingency plans.
- Ensure the continuous maintenance of the Trial Master File and Investigator Site File.
- Support the Project Manager and Clinical Team Leader in creating study-specific forms and ensuring timely completion and submission.
- Assist the start-up team or sponsor in obtaining regulatory document approvals and site contracts.
- Participate in Investigator Meetings and study-specific training sessions.
- Contribute to feasibility assessments and site identification efforts as needed.
- Prepare for and attend Assessment Visits with senior CRA, CTL, or Clinical Research Manager.
- Process interim and final payments to Investigators.
- Conduct in-house reviews of Case Report Forms (CRFs) and assist site staff in preparing for audits and inspections.
- Report quality issues and support root cause analysis and corrective actions.
- Contribute to country-specific, GCO, and CTO initiatives for enhancements and quality improvement.
- Independently manage multiple projects and tasks both individually and collaboratively.
Requirements:
- Minimum of three years of clinical monitoring or relevant clinical trial experience.
- Degree in life sciences, healthcare, nursing, or a related field.
- Proficient in medical terminology and clinical monitoring procedures.
- Exceptional communication skills in both local and English languages, both written and verbal.
- Outstanding interpersonal and organizational skills.
- Able to translate guidelines, rules, and regulations into clear recommendations.
- Customer-focused, approachable, and sociable demeanor.
- Capable of thriving in a challenging and fast-paced environment.
- Thorough understanding of therapeutic areas and protocols.
- Willingness to travel as required by project needs.
- Proficient in computer applications such as Word, Excel, and PowerPoint.
- Demonstrated ability to manage multiple projects and mentor colleagues.
- Keen attention to detail and excellence in administrative tasks.
Benefits:
- Comprehensive benefits package.
- Competitive salaries.
- Departmental Study/Training Budget for professional development.
- Flexible working hours.
- Option for remote/hybrid* work.
- Leadership and mentoring opportunities.
- Participation in our Buddy Program.
- Potential for internal growth and career advancement.
- Lucrative employee referral program.
- Access to online training via GoodHabitz and internal platforms.
- Eligibility for Spot Bonus and Loyalty Award Programs.
*Our hybrid work policy fosters a dynamic work environment, requiring 2 days in the office per week for employees located within proximity to one of our facilities.
Join Our Team and Drive Change
If you are eager to contribute to pioneering clinical research and be part of an inspiring team, take the next step to be a part of our team.
Let's deliver life-altering therapies to those in need.
