Senior Central Monitoring Associate - Sponsor-Dedicated - Germany

Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.

Why Syneos Health
• #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Here at Syneos Health we are currently recruiting for a Senior Central Monitoring Associate role to work home-based for one the world's leading Pharmaceutical companies in Germany.

The Senior Central Monitoring Associate is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws and Good Clinical Practices.

Your main responsibilities:

1) Clinical Trial Site Activation & Conduct

Initiate and coordinate activities and essential documents management towards the compilation of a high-quality Investigator Initiation Package (IIP)

Register investigator sites and systems as required.

Work directly and interact with investigator sites to complete critical information inclusive essential documents components, study contracts contacts, clinical supply shipment information, payment information, IRB submission

Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms

Take the Lead and Coordinates the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study

Coordinate the timely communication, documentation and responses between Pfizer and Central Ethics committee to bring clinical study to approval (country dependent)

Support investigators sites with local IRB workflow from preparation, submission through approval

Responsible for timely filing of documents to Trial Master File and other systems

Accurately update and maintain clinical systems that track site compliance and performance within project timelines

Lead or assist with the preparation, handling, distribution, filing, and archiving of clinical documentation

2) Communication

Maintain ongoing contact and communication with the study team

Attend study Start-up meeting and provide functional updates on a country and site level

3) Clinical Trial Site Support

Perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with study documentation

Identify and resolve investigator site issues within required timeframes

Be an SME on one or more system and/or process, be the go-to person and train the SAPs on these respective systems or processes

Mentor for new hires on processes, systems and activitiesWhat we're looking for

Bachelor's degree in Life Science

Min. 6 years of experience in clinical site activation

Experience with EC submissions required

Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements

Must demonstrate good computer skills and be able to embrace new technologies

Excellent communication, presentation and interpersonal skills

Moderate level of critical thinking skills expected

Fluency in German and English language

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Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.

Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.