Due Diligence Specialist in Clinical Trials
hace 5 meses
**Description**
**Due Diligence Specialist in clinical trials (CMA) English & Portuguese required Home Based Mexico**
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**
- Performs remote site qualification, site initiation, site monitoring calls, and close-out visits ensuring regulatory, ICH-GCP and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans. Develops a working knowledge and operates according to ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/Processes.
- May require knowledge of Good Pharmacoepidemiology Practices (GPP) and Good Epidemiologic Practices (GEP) guidelines for NIS and to adhere to a schedule of data collection from HCPs and patients for NIS, effectively employing technology for tracking.
- Applies query resolution techniques remotely and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Assesses site compliance with electronic data capture requirements.
- May perform Remote Aggregated Data Review (RADaR) utilizing the appropriate tools to identify, respond and manage issues in line with the associated Work Instructions (WI), RADaR guideline and Clinical Monitoring Plan (CMP)/Site Management Plan (SMP) for assigned sites/project. Ability to identify trends within a site, and across a number of sites, escalating issues and trends to, with guidance, develop corrective actions / preventative actions.
- Routinely reviews the site section of the trial master file (TMF) or project master file (PMF) in totality for NIS for accuracy, timeliness and completeness. Requests new/updated documents from the site, as required. If remote access is available to an electronic Investigator Site File (eISF), routinely reviews the eISF for accuracy, timeliness and completeness. Reconciles contents of the eISF with the TMF. Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
- For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. With oversight and direction, is able to quickly, adapt to changing priorities to achieve goals / targets.
- Acts as primary liaison with project site personnel or NIS reporters, in collaboration with the on-site CRA. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
- Prepares for and attends Investigator Meetings, Advisory Committee Meetings and/or other sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
- Provides guidance at the site and project level towards audi
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