Sponsor Dedicated - Project Data Manager - Multi LATAM Location

Syneos Health, Inc.; Colombia; In loco; COP 283.965.000 - 378.621.000; Tempo pieno

Descrizione del lavoro

Syneos Health is seeking a Sponsor Dedicated - Project Data Manager for a Multi LATAM Location. The role leads Data Management activities across projects, coordinating teams and ensuring delivery per SOPs and client agreements.

The candidate will manage resources, train staff, monitor progress, and participate in audits and sponsor meetings. Strong PM skills and CRO experience preferred; up to 25% travel may be required.

Competenze

• BA/BS in biological sciences or related field or RN; equivalent experience considered.
• Clinical data management experience or equivalent combination of education and experience.
• Experience with clinical data management practices and relational database systems.
• Strong project management skills and knowledge of PM methodologies.
• Demonstrated staff leadership ability; CRO experience preferred.
• Proficiency with MS Office tools and excellent communication skills.

Mansioni

• Act as Functional Lead for Data Management and primary liaison among Data Management, Project Management and Clinical Monitoring.
• Coordinate the work of the Data Management/Data Operations team.
• Ensure timely delivery of Data Management activities per SOPs and regulations.
• Provide project-specific training to internal and external audiences.
• Oversee financial aspects including revenue recognition and scope changes.
• Communicate project progress using status reports and metrics.
• Develop and maintain project plans and documentation in line with SOPs.
• Maintain TMF filing and participate in audits.
• Mentor and train data management staff.
• Support bid defense meetings and proposal inputs.
• Maintain proficiency in Data Management systems through training.

Conoscenze

Project management

Leadership

Communication

Time management

Multitasking

Formazione

BA/BS in biological sciences or related field

Registered Nurse (RN)

Strumenti

Oracle Clinical

Rave

Inform

Descrizione del lavoro

Sponsor Dedicated - Project Data Manager - Multi LATAM Location

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

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 deliver - for one another, our customers, and, most importantly, for those in need.

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 building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

• 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 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
• 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 complete and 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
• Prepares input for, and participates in proposal bid defense meetings
• Maintains proficiency in Data Management systems and processes through regular training
• Performs other work related duties as assigned. Minimal travel may be required (up to 25%)

Qualification:

• 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 of 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.

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