Company: SynteractHCR Deutschland GmbH
Location: Morrisville, NC
Closing Date: 04 Dec 16
Type: Full Time
Salary (£): On Application
Overview The Associate Director, Clinical Data Management manages the day-to-day activities of the Clinical Data Management functions with an emphasis on effective resourcing and developing of personnel. S/he provides Clinical Data Management oversight (DMO) for assigned Sponsors; coordinates inter-departmental and Sponsor communication, helps resolve administrative, personnel, and site issues. Additionally, the Associate Director, Clinical Data Management is responsible for cross...
The Associate Director, Clinical Data Management manages the day-to-day activities of the Clinical Data Management functions with an emphasis on effective resourcing and developing of personnel. S/he provides Clinical Data Management oversight (DMO) for assigned Sponsors; coordinates inter-departmental and Sponsor communication, helps resolve administrative, personnel, and site issues. Additionally, the Associate Director, Clinical Data Management is responsible for cross functional standardization and harmonization, technology and process improvement and resource forecasting. S/he collaborates with department head on the ongoing development of the Clinical Data Management function, contributes to the business plan at both the tactical and strategic levels, and facilitates certain initiatives/special projects such as department level Clinical Data Management training, software and/or systems analysis or implementation. This role may be located in our Carlsbad, CA or Morrisville, NC office.
Reviews the design of media for data collection (CRF).
Reviews Data Management Plans, edit check specifications, CRF Completion Guidelines and Quality Control (QC) plans developed by the team.
Ensures that all team members have been sufficiently trained.
Communicates with Sponsors and project teams as needed regarding data, database or relevant project issues.
Ensures that any requests or needs of Sponsors during the course of the project have been met.
Provides input into project timelines and ensures that adequate resources are utilized to meet timelines.
Understands the sequence of running programs to ensure up-to-date data and to troubleshoot problems. May use SAS to develop, program and maintain any output needed within the Clinical Data Management group. Able to use SAS to review clinical datasets.
May present software demonstrations and/or project-specific CRF instructions at Sponsor meetings or bid defenses.
May facilitate communication between the Clinical Data Management team and other departments at the Company. May facilitate communication with the Sponsor, sites, or monitors.
Reports the status and progress of projects to the head of Clinical Data Management on an on-going basis.
Serves as a Clinical Data Management representative, overseeing the work done for assigned Sponsors, ensuring that there is back-up, continuity, and responsiveness, and that tasks are performed in a timely manner for all projects for these Sponsors.
May control project budget; appropriately escalates issues to department management.
Provides operational input into proposals, including participation in Sponsor presentations; exhibits credibility and expertise in Business Development activities with existing and potential new Sponsors.
Provides technical expertise and problem resolution across functions, projects and customers.
Assists with resource management, including reviewing the productivity and utilization of the group.
Assists with the coordination of department operations and project deliverables; supports continued growth through the development and management of the department ensuring optimal performance; supports continued improvement through implementation of processes and technologies.
Writes/reviews/updates Clinical Data Management related Standard Operating Procedures (SOPs).
Contributes to the annual budget process; performs data gathering and provides input to spending/anticipated spending, at the department level.
Supervisory responsibilities include but are not limited to providing technical and operational guidance and direction, checking output of work, ensuring deliverables are met, and administering company policies including pay programs and performance management.
Academic & Professional Qualifications:
Skills & Experience:
Completion of a Clinical Trials certification is an asset.
SCDM-Certified Clinical Data Manager is an asset.
Comprehensive understanding of relevant company practices.
Proficiency with Microsoft Office: Word, Excel, Outlook, PowerPoint.
What We Have to Offer
Our team-oriented organization is collaborative and diverse; our work is interesting and challenging; and every individual has an opportunity to thrive, grow, and achieve success in his or her position. We are proud of our reputation in the industry for quality services and specialized teams dedicated to meeting or exceeding client expectations
Who We Are
SynteractHCR is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development. With our “Shared Work – Shared Vision” philosophy we provide customized Phase I through IV services collaboratively and cost effectively ensuring on-time delivery of quality data so clients get to decision points faster. Operating in 15 countries, we deliver trials internationally, offering expertise across multiple therapeutic areas including notable depth in oncology, CNS, infectious disease, endocrinology, cardiovascular and respiratory, among other indications.
Our mission is to support the innovation and development of better therapies in healthcare. Our focus on patients’ safety and comfort helps us to establish ethical standards for everything we do.
SynteractHCR’s policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with SynteractHCR must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire.
SynteractHCR Deutschland GmbH
|Tel:||+49 89 12 66 80 0|
|Fax:||+49 89 12 66 80 2444|
|Website:||Visit Our Web Site|
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