Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

Tailor your resume to this Clinical Trial Manager role.

Rezi rewrites your resume against Syneos Health's job description. Free.

Resume score gauge reading 58 out of 100

Don't guess if your resume is good enough.

See how it scores against the Clinical Trial Manager posting at Syneos Health — free, in seconds.

About the Role

Syneos Health is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success by translating clinical, medical affairs, and commercial insights into outcomes. Our Clinical Development model prioritizes the customer and patient, and we continuously strive to simplify our work to be easier to work with and for. Join us to collaborate with passionate problem solvers and innovate as a team to help customers achieve their goals, accelerating the delivery of therapies and changing lives.

Responsibilities

Perform site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remotely) ensuring regulatory, ICH-GCP, GPP, and protocol compliance.
Evaluate overall site and staff performance, providing recommendations and developing action plans for serious issues.
Maintain knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.
Verify informed consent process documentation and protect subject/patient confidentiality.
Assess factors affecting subject/patient safety and data integrity, including protocol deviations and pharmacovigilance issues.
Assess site processes according to the Clinical Monitoring/Site Management Plan (CMP/SMP).
Conduct Source Document Review of appropriate site source documents and medical records.
Verify accuracy and completeness of clinical data entered in the case report form (CRF).
Apply query resolution techniques remotely and on-site, guiding site staff to closure within timelines.
Utilize hardware and software for effective clinical project data review and capture.
Verify site compliance with electronic data capture requirements.
Perform investigational product (IP) inventory, reconciliation, and review storage/security.
Verify IP dispensing and administration according to the protocol and review issues related to blinded or randomized IP.
Ensure IP is appropriately (re)labelled, imported, and released/returned according to GCP/local regulations and organizational procedures.
Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness.
Reconcile ISF contents with the Trial Master File (TMF).
Ensure investigator/physician sites are aware of essential document archiving requirements.
Document activities via confirmation letters, follow-up letters, trip reports, and communication logs.
Support subject/patient recruitment, retention, and awareness strategies.
Enter data into tracking systems for observations, status, and action items.
Manage site-level activities and communication to meet project scope, budgets, and timelines.
Adapt to changing priorities to achieve goals/targets with oversight from the Lead CRA.
Act as a liaison with project site personnel or collaborate with other CRAs/Central Monitoring Associates.
Ensure all assigned sites and project-specific team members are trained and compliant.
Prepare for and attend Investigator Meetings and sponsor face-to-face meetings.
Participate in global clinical monitoring/project staff meetings and attend clinical training.
Provide guidance on audit readiness standards and support audit preparation and follow-up actions.
For Real World Late Phase, perform site support, chart abstraction, data collection, and collaboration with Sponsor affiliates, MSLs, and local country staff.
Adhere to knowledge of local requirements for real-world late-phase study designs.

Requirements

Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
Demonstrated good computer skills and ability to embrace new technologies.
Excellent communication, presentation, and interpersonal skills.
Ability to manage required travel of up to 75% on a regular basis.
Must comply with Site requests for medical and other personal information for facility access as a condition of employment.
Must comply with local guidelines and regulations for archiving essential documents.

Skills

Clinical monitoring
Site qualification
Site initiation
Interim monitoring
Site management
Close-out visits
Regulatory compliance
ICH-GCP
Good Pharmacoepidemiological Practices (GPP)
Protocol compliance
Informed consent process
Subject/patient confidentiality
Subject/patient safety assessment
Clinical data integrity
Protocol deviation/violation assessment
Pharmacovigilance issue assessment
Clinical Monitoring/Site Management Plan (CMP/SMP) assessment
Source Document Review
Case Report Form (CRF) data verification
Query resolution
Electronic data capture (EDC) compliance
Investigational Product (IP) management
Investigator Site File (ISF) review
Trial Master File (TMF) reconciliation
Document management
Subject/patient recruitment support
Subject/patient retention support
Subject/patient awareness strategies
Data tracking systems
Project scope management
Budget management
Timeline management
Communication
Presentation skills
Interpersonal skills
Adaptability
Problem-solving
Audit readiness
Real world late phase study designs
Chart abstraction
Data collection
Collaboration

Location

US ONLY

Work Type

On-site
Remote
Full-time

Experience Level

Entry Level

Education Level

Bachelor's degree
RN

Benefits

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program

About the Company

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.
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.
When we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
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.

Equal Opportunity

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.
The Company is committed to compliance 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.