Syneos Health is currently looking to strengthen our team in South-Africa at our location in Bloemfontein. Currently we are looking for a Manager, Clinical Data Management.
In this role you are responsible for line management and functional support of Clinical Data Associates (CDAs) within their group.
Recruitment, staff mentoring and development, resource management, project finance, operational project support, and sponsor communication are among those duties.
The main responsibilities of this role are : Line management responsibilities including professional development, performance appraisals, and employee counseling for junior and management staff.
Assigns project work and reviews workload for all direct reports. Manages staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level.
Provides staff performance development and utilizes mentoring and coaching techniques, performs regular performance reviews, and implements disciplinary actions if necessary.
Works with the Associate Director / Director to support the recruitment / interviewing process. Manages the resource / workload of the team, assigns tasks to team members, and subsequently monitors productivit / utilization, timeliness, and quality.
Ensures team awareness of evolving working practices / policies / work instructions. Holds regular data management team meetings to communicate study / departmental information.
Keeps senior management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner.
Balances multiple task assignments and communicates needs to supervisor to obtain needed resources. Additionally, maintains the departmental resource tracking tools.
Functions as a Lead Data Manager (LDM) on one or more studies as required and will, therefore, be responsible for managing sponsor relationships for all assigned studies.
Proactively manages the scope, budget, and resource for their assigned studies under the guidance of an Associate Director / Director.
May also be required to function as a Clinical Data Associate (CDA). Serves as the sponsor liaison when there are multiple studies running concurrently for one sponsor and ensures consistency and continuity amongst the study teams.
Identifies best practices and investigates root causes across fundamental issues and problems for projects and recommends solutions.
Prepares / maintains the necessary information to support the regular project review, including revenue (hard / soft, predicted, and actual), change orders, milestone / metrics, invoicing, exsums, and resourcing.
Represents Data Management in project related cross-functional study team meetings. Performs cross-functional communications where issues are judged to need clarification and or resolution.
Assists Senior Director / Director with budgets and resource needs at department and project level. This will including reviewing, editing / managing project bids / proposals, contracts, and scope changes at the project level.
Maintains overall awareness in the field of clinical data management by reading related literature, self-training, attending training classes, etc.
Maintains current professional knowledge in fields of information management, quality assurance, regulatory affairs, and applicable areas of medical sciences to serve as a basis for providing value added expanded Company services to all appropriate sponsors.
Establishes and maintains Standard Operating Procedures (SOPs) for Data Management and participates in the review and approval of other related SOPs.
Responsible for establishing and maintaining accurate quality metrics for Data Management and for continuous monitoring to ensure compliance.
May also be involved with the development of departmental training materials and help support the implementation of new technologies / services.
Provides support to Business Development staff by participating in presentations to sponsors and in reviewing proposals and contracts.
We are looking for enthusiastic new colleagues with the following qualifications : BS / BA in the biological sciences or related discipline in the natural sciences / health care field or equivalent combination of experience and education.
Advanced degree preferred. Moderate experience in Data Management in a pharmaceutical or biotech company or contract research organization with staff management experience.
Inform experience strongly preferred. Experience in a contract research organization preferred. Some experience with database management software systems.
Demonstrated leadership experience within a team matrix environment. Working knowledge of regulatory requirements for clinical studies.
Good knowledge of medical terminology, clinical data, and ICH / Good Clinical Practices. Proficiency in Word, Excel, PowerPoint, and email.
Demonstrated experience in managing multiple priorities in a highly dynamic environment. Strong judgment and tactful discretion.
Effective oral and written communication skills, presentation skills, and attention to detail. Ability to multitask under deadlines and work as part of a multidisciplinary team as well as independently.
Ability to be flexible and adapt to change. Are you interested to join our South-African team? We are looking forward to receive your application! About us : Why Syneos Health?
Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 24,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.
Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator.
You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past.
Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-
deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world. #LI-IH2