Description:
Location: Bavaria, Germany - Home-based

Schedule: Full-time, Permanent

TalentSource Life Sciences, the CROMSOURCE flexible resourcing department, is currently working with one of our partner sponsors to hire a Lead Clinical Research Associate (LCRA). The Lead CRA will be involved in all field-based clinical research site activities to ensure the overall integrity of study implementation, and adherence to the study protocol at assigned clinical sites ensures trial execution is carried out to the highest standard.

This is a rare opportunity to join a US Medical Technology company as a permanent employee, where you will be able to grow your career and take advantage of their great benefits package!

Main Job Tasks and Responsibilities:

• Manage and oversee the work of assigned teams and may indirectly manage cross-functional or matrix teams as appropriate.
• Responsible for team budget and outside contractors/vendors.
• Develop a robust talent development plan in alignment with the functional growth strategies of the department.
• Lead on the strategic direction of field monitoring of studies and data collection for clinical trials (e.g., increased volume, upstream clinical projects) with increased volume and complexity (e.g., Key Opinion Leader (KOL) site).
• Assess all data documentation, reports, records, transcripts, and exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within the parameters of the study hypothesis, as well as monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements.
• Provide guidance to the team for clinical trial conduct improvements including management of metrics (e.g., dashboard), compliance, protocol deviations, and data entry cadence.
• Lead in the development of technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, and regulatory documentation requirements as well as training and proctoring new employees on a trial and study-related activities.
• Act as a mentor to new or other employees across the company.
• Lead team members to take appropriate actions on complex trial monitoring issues (e.g., CAPA) and review escalated monitoring visit reports.
• Participate and contribute to the development of clinical protocols, Informed Consent Forms, and Case Report Forms.
• Resolve complex trial/study data and regulatory documentation.
• Provide direction and guidance to execute project deliverables in collaboration with project managers.
• Initiate and lead the implementation of clinical process improvement opportunities.

Education and Experience:

• Bachelor's Degree in a related field with previous field monitoring experience, quality assurance/control, and regulatory compliance required.
• Master's Degree or equivalent Experience working in a regulated industry preferred.
• Demonstrated track record in people management is required.

Specific Role Requirements and Skills:

• Proven expertise in MS Office Suite, including Word, Excel, and Adobe.
• Experience with Electronic Data Capture preferred.
• Excellent written and verbal communication skills including negotiating and relationship management skills with the ability to drive the achievement of objectives.
• Excellent problem-solving, organizational, analytical, and critical thinking skills.
• Expert understanding of clinical studies procedures while addressing issues with impact beyond own team based on knowledge of related disciplines
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to work and excel within a fast-paced, dynamic, and constantly changing work environment.
• Frequently interacts with customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company.
• Participate and present at meetings with internal and external representatives

Benefits of Working for our Client:

• Competitive Compensation and Benefits package
• Flexible working hours, remote working
• Pension plan
• Insurance
• Meal voucher
• Service Awards
• Annual Leave
• Transportation allowance
• Employee Stock Purchase Program
• Employee Assistance Program
• Comprehensive Wellness Program including an onsite gym, yoga classes and massage, preventive health checks, healthy lifestyle webinars, educational events, charity activities, and much more.

The Application Process:

Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs please contact careers@cromsource.com for more information.

Who are CROMSOURCE:

CROMSOURCE is an independent, international Contract Research Organisation (CRO) operating in over 40 Countries and 16 offices with approximately 500 professional team members, making it one of the largest independent CROs in Europe. Our international headquarters are located in Italy and USA, with local offices in Belgium, The Netherlands, Germany, Poland, Russia, Spain, Switzerland, and the United Kingdom.

By joining our client teams, you can be part of making a difference in the lives of people and experience a fulfilling and rewarding career. Together, we help our clients succeed in their work developing medicines and medical devices for patients around the world.

Keywords: Manager for the Lead Clinical Research Associate, Lead CRA Manager, Lead Clinical Research Associate Manager, Clinical Operations Lead, Clinical Operations Manager, COL, COM, Clinical Research Manager, Clinical Team Manager, CTM, Senior Manager CRA, CRA Manager Lead, Senior Clinical Study Manager, Medical Technology, Pharmaceutical Company, Pharmaco, Pharmaceutical, Sponsor-dedicated
Skills: Clinical Lead, Clinical Operations Manager, Clinical Research Manager, Head of Clinical Operations, Clinical Research Organisation, clinical trials, CRO, Pharma, Pharmaceutical, Project Leadership Location: Germany