Career Opportunities at Syneos Health Clinical Solutions

Job Responsibilities

• Uses SAS or other software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications.
• Works to ensure that outputs meet quality standards and project requirements.
• Performs validation programming and works with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings.
• Keeps project team members informed of programming progress and issues requiring their attention.
• Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
• Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness.
• Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload.
• Develops specifications for datasets and outputs of any complexity according to statistical and sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework.
• Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others.
• Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus.
• Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
• Negotiates and establishes accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and completes project programming activities within timeframe allotted.
• Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables.
• Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities.
• Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor.
• Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process.
• Transfers deliverables.
• Performs other work-related duties as assigned.
• Minimal travel may be required

What We’re Looking For

• Extensive ADaM experience - TFLs
• Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience.
• Extensive programming experience in SAS or other required software, preferably in a clinical trial environment.
• Excellent written and verbal communication skills.
• Ability to read, write, speak and understand English.

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Job responsibilities;

The position provides customer focused leadership in managing and delivering the operational and financial aspects of one or more clinical projects from proposal development to final deliverables and ranging in size and complexity from single service studies to full scope, multiple protocol projects and/or global projects across various phases and functional areas with limited interaction from supervisor. May oversee less experienced Project Managers (PMs) and have line management responsibilities.

Project Leadership and Delivery:

• Manages a project as Project Manager overseeing interdisciplinary clinical research programs ensuring compliance with Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs) and regulatory requirements.
• Acts as primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer’s and the Company's contractual agreement.
• Leads clinical team to ensure quality, timelines and budget management.
• Accountable for the financial performance of assigned projects
• Accountable for all project deliverables for assigned projects and/or project regions.
• Coordinates activities and deliverables of all project conduct partners and proactively identifies and manages issues.

Reporting and Communication:

• Accountable for maintenance of project information on a variety of databases and systems.
• Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools.  
• Responsible for project management components of inspection readiness for all aspects of the project conduct, including Trial Master Files. 
• Provides oversight for development and implementation of project plans in accordance with Controlled Documents.
• Independently prepares, coordinates, and presents project material at internal and external meetings. 
• Directs the activities of assigned Project Support staff; line manages and mentors other project management team members and clinical staff; facilitates team building and communication.
• Prepares project management reports for clients and management. 
• Implements resource strategies to achieve project goals.
• Develops contingency planning and risk mitigation strategies to ensure successful delivery of project goals. 

Business Development:

• Participates in bid defense meetings where presented as potential project manager/director.
• Develops strong relationships with current clients to generate new and/or add-on business for the future.  
• Keeps a current awareness of business unit’s and assigned projects’ therapeutic environment and drug development trends  

Management:

• May train and support new Project Managers. Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training.
• May be required to line manage other project management team members and clinical monitoring staff

Qualifications

What we’re looking for;

• Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience.
• Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
• Clinical research organization (CRO) and relevant therapeutic experience preferred.  
• Prior experience as Project Lead is required.
• Direct therapeutic area expertise.
• Strong ability to manage time and work independently.
• Strong organizational skills.
• Ability to embrace new technologies.
• Excellent communication, presentation, interpersonal skills, both written and spoken.
• Flexibility and the ability to mentor and manage new staff and to handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment.
• Ability to travel as necessary (less than 25%).

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Job responsibilities 

• Works under minimal guidance and supervision of a line manager or delegate to assess the level of data required and approaches for RFPs and individual paid feasibility assessments.
• Ability to manage and fulfill an average number of assignments concurrently. Requires little assistance with standard requests, is able to manage non-standard requests with guidance.
• Assesses needs & independently liaises with internal stakeholders to review sponsor requirements, protocol, and timelines for individual RFPs.
• Some contribution for development and achievement of departmental business objectives.
• Liaises with Business Units, Business Development, Medical Directors, Business Analysts, and other members of the team to review sponsor requirements, protocol, and timelines for individual RFPs. Guided research of data assets and scientific literature using internet and internal facilities to provide background information. Includes query of relevant databases, including clinical trial registry tools and internal sources, and research various literature sources to support preparation of robust feasibility.
• Maintains comprehensive records of work and stores all relevant data within internal libraries in a timely manner.
• Provides review and assessment of the outcomes of pre-award site level outreach along with standalone feasibility assessments to inform on site selection, enrollment, and site activation activities.
• Build and maintain relationships with internal and external stakeholders to develop clear communication methods to support study strategies with minimal adjustments

Qualifications

What we’re looking for

• BS/BA in Science with an emphasis in medical research
• Flexible, creative, and open to suggestions.
• Self-motivated and ability to work both independently and as a critical part of a team.
• Ability to understand and process scientific and clinical research documents.
• Working independently, in a virtual team environment
• Understanding and presenting complex scientific and clinical research data and analysis methodologies
• Knowledge of principles, concepts, practices, and standards in the CRO industry
• Effective text development
• Working and managing individuals and data to drive business objectives.
• Attention to detail
• Advanced Microsoft Office Suite (e.g., Word, Excel, PowerPoint, database applications), email, and internet research capabilities.
• Strong organizational, interpersonal, and team-oriented skills
• Excellent verbal, editor-level written, communication proficiency.
• Excellent time management skills; ability to perform several tasks simultaneously to meet deadlines in a dynamic environment
• Ability to be flexible, adapt to change, as well as work collaboratively as part of a team
• Must be flexible around travel and work hours if a business need should arise. Travel minimal less than 5%