Vacancies at Syneos Health Clinical Solutions

Job Summary
The Analyst supports the development, education, monitoring, and implementation oversight of enterprise information security policies and standards. The Analyst primary focus is to assist with the administration of information security governance and compliance processes and monitoring and reporting information security policy and program compliance.

Job Responsibilities

• Performs vendor security assessments and security reviews to assess the security posture and capabilities of Syneos Health vendors
• Monitors Syneos Health vendors to ensure they are meeting Syneos Health vendor security requirements
• Monitors, and reports on information security governance, risk and compliance key performance indicators
• Assist with preparing and submitting mandatory information security program compliance reports to management, and clients
• Assist with preparing responses to internal and external inquiries about information security program, compliance, and performance
• Helps administer information security governance review and approval procedures
• Collaborates with other security organization members on cross-business / cross-functional opportunities
• Helps perform security data analysis and event tracking
• Responds to reported security incidents and events through the Company’s ticketing system
• Helps with writing documentation and reports
• Evaluates new security technology in the Company environment
• Other duties as assigned

Qualifications

• Experience with leading information security frameworks and policy concepts.
• Bachelor’s Degree (or higher) preferred (or equivalent experience).
• Industry certifications such as CISA, CRISC, CISSP or similar industry certification desirable.
• Proficient with Microsoft Office Suite (Word, Excel, Power Point).
• Professional with ability to properly handle confidential information.
• Ability to work well independently and in a team environment. Ability to handle multiple tasks, prioritize and meet deadlines. Ability to work within a matrix organization.
• Must have flexibility and willingness to participate in the work processes of an international organization, including conference calls scheduled to accommodate global time zones.
• Understanding of security tools such as firewalls, anti-malware, Intrusion Detection/ Intrusion Prevention systems (IDS/IPS), Data Leak Prevention (DLP), Unified Threat Management (UTM).
• Familiarity with common information security standards such as ISO-27000 and NIST SP 800 series.
• Ability to review reports and system activity logs to identify critical events, categorize according to priority, and escalate as appropriate

go to method of application »

Job 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, regulatory requirements, drug development process and clinical monitoring procedures.
• Clinical research organization (CRO) and relevant therapeutic experience preferred.
• Strong ability to manage time and work independently.
• 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 (approximately 25%).

go to method of application »

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

Qualifications
What we’re looking for

• 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.

go to method of application »

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%)

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