Description
Pharmacy Site Monitor (CRA I) - FSP client dedicated - Western Germany - home based
Here at Syneos Health we are currently recruiting for a Pharmacy Site Monitor (CRA I)opening,to work on a sponsor-dedicated role in the Southwest of Germany, performing onsite monitoring visits in pharmacies around Mannheim, Heidelberg, Frankfurt, Nürnberg. and the surrounding areas. It is a permanent, full-time, home-office position. This role is part of our FSP 360 team (functional service provider), which is designed to successfully meet the individual needs and goals of the client you will be supporting.
Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- 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.
Job responsibilities:
Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits for all pharmacy-related topics.
- Conducts Site Initiation visits in collaboration with RCO Site Managers and RCO Site Monitor where applicable, to orient and train site personnel regarding the protocol and applicable regulatory requirements.
- Evaluates potential pharmacies to assist in the placement of planned clinical studies
- Critically reviews and analyzes pharmacy activities through on-site and off-site visits as per the monitoring plannd applicable client SOPs, to assure compliance with the protocol, ICH and/or FDA GCP Guidelines and other local regulations. This includes, but is not limited to: - Manages multiple protocols, across therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
- Must understand and follow the monitoring methodology assigned to the study as per the SMP which may include Risk-Based monitoring, reduced Source Data Verification or 100% Source Data Verification.
- Ensures quality of data submitted from pharmacies and assures timely submission of data.
- Ensures safety and protection of study subjects according to the monitoring plan, client SOPs, and ICH and FDA GCP Guidelines and local regulations (i.e. HC).
- Monitors activities of pharmacy personnel to meet study objectives.
- Anticipates and proactively solves study pharmacy problems/issues as they occur. Initiates, recommends and communicates corrective actions as needed.
- Ensures documented follow-up to all outstanding issues, within the scope of this position profile.
- Appropriately escalates serious or outstanding issues to line manager and project team members.
- Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits for all pharmacy-related topics.
- Conducts Site Initiation visits in collaboration with RCO Site Managers and RCO Site Monitor where applicable, to orient and train site personnel regarding the protocol and applicable regulatory requirements.
- Evaluates potential pharmacies to assist in the placement of planned clinical studies
- Critically reviews and analyzes pharmacy activities through on-site and off-site visits as per the moni