Global Clinical Trial Manager

19 hours ago

مصر, Egypt Syneos Health Clinical Full time

**Description**

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**

The Clinical Trial Manager II (CTM II) serves as the clinical functional lead, accountable for the delivery of
site management, clinical monitoring and central monitoring of assigned study(ies). A CTM II is expected
to independently manage the clinical and central monitoring team members, but may serve as a regional
clinical lead on larger trials under the direction of a global Sr CTM. The position as defined by scope
provides leadership, problem-solving, mentoring, and technical support to the Clinical Operations team to
ensure compliance with the monitoring plan as well as ensures timeliness and quality of deliverables
within the specified budget.

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/CeMs) 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 (eg. 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 f

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