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Pre Approval Access Manager Associate

Posted on Dec. 24, 2024

Remote, Australia
0 - 0 USD (yearly)

Full Time

Description

Clinical Trial Manager

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

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

Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.

Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities.

May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).

Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/Central Monitors) is aware of the contractual obligations and parameters.

Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.

Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope.

Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.

Participates and presents in key meetings such as Kick Off Meeting.

Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members. This may include accompanying CRA team members to sites for observation or conflict resolution.

Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines. Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities.

Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan. Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed. Ensures access and audit trail reviews are conducted as required.

Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study.

Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality.

Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools.

Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs),Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan.

Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan. Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans.

Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity. Document requested revisions and approvals in CTMS. Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines.

Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables. Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements. Provides solutions for obstacles in protocol execution and site management.

Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations. This may include data management, study start up, patient recruitment, medical monitoring, pharmacovigilance and Quality Assurance (QA). Supports Inspection Readiness for clinical trial management scope.

Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks. May develop and support execution of corrective action plans at site and study level. Supports and completes activities to achieve data cut and lock deadlines.

Provides feedback to line managers on staff performance including strengths as well as areas for development.

Qualifications

What we're looking for

Bachelor's degree or RN in a related field or equivalent combination of education, training and experience

Ability to lead and align teams in the achievement of project milestones

Capable of working in an international environment

Previous clinical trial experience in site management

Preferred experience with risk-based monitoring and clinical or central monitoring

Familiar with financial principles and budget management practices

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

Must demonstrate good computer skills

Good communication, presentation and interpersonal skills among project team and with sites

Basic conflict resolution skills

Ability to apply problem solving techniques to resolve complex issues and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project.

Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues

Moderate travel may be required, approximately 20%

Get to know Syneos Health
.Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. 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.

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