Job Description

Job responsibilities

• On a stand-alone project acts as Project Leader, including primary Sponsor contact for all contracted Data Management activities and deliverables. On a full service project acts as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups
• Coordinate the work of the assigned Data Management/Data Operations team
• Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations
• Provides project specific training to internal and external audiences as required
• Responsible for financial management of assigned projects / programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed
• Monitors and communicates project/program progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management
• Supports the management of resources on assigned projects/programs
• Plan, manages and requests resources for assigned projects
• Develop and maintain project plans, specifications and documentation in line with SOP requirements
• Maintains documentation on an ongoing basis and ensures that all TMF filing is up to date
• Participates in, and presents at internal, Sponsor, third-party, and investigator meetings
• Plans for and creates necessary documentation to support internal and external audits; participates in such audits
• Trains and mentors data management staff, acts as a subject matter expert
• Prepares input for, and participates in proposal bid defense meetings
• Maintains proficiency in Data Management systems and processes through regular training. May attend/represent the company at professional meetings/conferences
• Performs other work related duties as assigned. Minimal travel may be required (up to 25%)

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Sr Project Data Manager (Canada Home based)
Updated: November 16, 2022
Location: Canada-North America - CAN-Home-Based, Canada
Job ID: 22010255

Description

Senior Project Data Manager

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

• On a stand-alone project acts as Project Leader, including primary Sponsor contact for all contracted Data Management activities and deliverables. On a full service project acts as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups
• Coordinate the work of the assigned Data Management/Data Operations team
• Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations
• Provides project specific training to inte

...

rnal and external audiences as required

• Responsible for financial management of assigned projects / programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed
• Monitors and communicates project/program progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management
• Supports the management of resources on assigned projects/programs
• Plan, manages and requests resources for assigned projects
• Develop and maintain project plans, specifications and documentation in line with SOP requirements
• Maintains documentation on an ongoing basis and ensures that all TMF filing is up to date
• Participates in, and presents at internal, Sponsor, third-party, and investigator meetings
• Plans for and creates necessary documentation to support internal and external audits; participates in such audits
• Trains and mentors data management staff, acts as a subject matter expert
• Prepares input for, and participates in proposal bid defense meetings
• Maintains proficiency in Data Management systems and processes through regular training. May attend/represent the company at professional meetings/conferences
• Performs other work related duties as assigned. Minimal travel may be required (up to 25%)

Qualifications

What we\'re looking for

• BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse. In lieu of degree, equivalent relevant work experience.
• Clinical data management experience or an equivalent combination of education and experience.
• Experience in Clinical Data Management practices and relational database management software systems.
• Strong project management skills and knowledge of project management methodologies
• Demonstrated staff leadership skills.
• Contract Research Organization (CRO) experience preferred.
• Direct exposure to Oracle Clinical, Rave, or Inform systems. Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices.
• Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications.
• Effective oral and written communication skills.
• Strong presentation skills
• Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail.
• Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team.
• Ability to make effective decisions and manage multiple priorities in a highly dynamic environment.
• Knowledge of ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Management

Requirements

• Essential - BA/BS in the biological sciences or related field
• Essential - Clinical data management experience
• Essential - Effective oral and written communication skills.

Knowledge and abilities

• Essential - Direct exposure to Oracle Clinical, Rave or Inform
• Essential - Proficiency in MS Windows navigation, Word, Excel

Relocation/Travel requirements : Upto 25%

Syneos Health Clinique Inc.

We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it...

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