INC Research looking for Clinical Project Data Manager

For more than 20 years, as Albany Molecular Research Inc. (AMRI), we have provided fully integrated drug discovery, development and manufacturing services – all while adapting to the rapidly changing needs of our customers within the pharmaceutical, biotechnology and related industries. With locations in the United States, Europe and Asia, AMRI SMARTSOURCING™ offers you a versatile and strategic way of partnering with us that is designed to deliver reduced risk, greater flexibility and a better return on investment. AMRI has successfully partnered R&D programs and is actively seeking to out-license its remaining programs for further development.

Post : Clinical Project Data Manager

Summary: Ensures the contracted Data Management for clinical studies are carried out by the Company in accordance with the executed contract and the customer’s expectations.

Essential Functions:
Acts as Project Leader on a stand alone contract ("project") for Data Management, to include:
a. primary customer contact for all contracted Data Management;
b. direct liaison with Finance and Contract department on required matters (e.g., invoicing, contract changes).
Acts as Functional Lead for Data Management on full service contracts to include:
a. primary contact for internal liaison between Data Management and Company Project Management, Clinical Monitoring, and other functional groups on 'full service' contracts;
b. liaison with Finance and Contracts groups via the Project Leader (e.g., concerning invoicing, contract changes).

Ensures launch, delivery and completion of all Data Management according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations.
Manages changes of scope, budget, revenue recognition, and participation in monthly internal project reviews.
Monitors and communicates project progress to the customer and project team including use of project status reports and tracking tools/metrics.
Plans, manages, and requests resource as required for assigned studies.
Maintains a consistent, manageable workflow for Data Management project team by monitoring enrollment information and communicating with project team to actively influence data collection.

Develops and maintains:
a. Data Management Plans;
b. Project Management Plans (for stand-alone contracts only);
c. Communication Plans (for stand-alone contracts only);
d. SAE Reconciliation Guidelines;
e. Quality Plans; and other plans as delegated/required.

Reviews and approves:
a. project plans and guidelines for data validation, electronic data interchange, coding, CRF/eCRF screen, database design, user testing, CRF tracking, CRF/eCRF completion and other applicable project plans as delegated/required;
b. specifications for listings and summaries (other than for statistical reporting requirements) from CRF databases, and external data sources;
c. output from listings and summaries (other than for statistical reporting requirements) from CRF databases, and external data sources.

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Requirements:
BA/BS in the biological sciences or related disciplines in the natural science/health care field. Moderate clinical data management experience or an equivalent combination of education and experience. Experience Clinical Data Management practices and relational database management software systems. 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. 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.

Additional Information:
Qualification:Bachelor Degree
Location:United States
Industry Type: Pharma