Lead Clinical Data Manager.

JOB DESCRIPTION:

The Clinical Data Manager will have a demonstrated ability to oversee the data management activities across a single clinical program or group of related studies. Provides Data Management leadership and expertise to project and study teams. Will have an good knowledge of the end to end clinical research and data management processes, as well as global regulatory and industry rules and guidances (i.e. ICH, GCP) to support drug development processes and global project submissions through to approval. Responsible for managing data management components of project and study budgets and vendor performance. May mentors team members and more junior staff and may direct activities of contract Data Manager staff.

Job Function and Description Delivering Excellence:

Takes leadership role in project implementation. As a member of the clinical study or project team, ensures oversight of the Data Management CRO. Provides status reports/updates, resolves disputes, and ensures timely acquisition of high quality deliverables from the CRO Provides Data Management expertise to the team in identifying opportunities for process and budgetary optimization Coordinates with Biostatistics and Statistical Programming to ensure appropriate design, documentation, testing and implementation of SAS data deliverables according to internal and regulatory standards. Works with team members via matrix relationships (internally or at CROs) by directing work, resolving problems and/or providing guidance

• Accountability and Ownership: Drives accountability at every possible level Ensures Data Management CROs are delivering quality data and documentation on time, on budget and to company’s quality standards and SOPs Reviews Data Management CRO performance measures and evaluates cost/benefit of actions taken to remedy or improve performance Collaborates with CRO and study team members to identify and resolve issues impacting goal attainment.

• Judgment and Decision Making:Evaluates immediate business impact and takes decisive action Provides within and between study comparisons of DM timelines for assigned projects. Takes action to ensure study and project priorities are maintained; ensures adjustment of plans as priorities evolve Contributes to regular budget forecasting and regular cost accrual processes and proactively communicates to the team budgetary impacts of decisions or processes implemented to achieve results

• Courage to challenge: Takes risks and challenges norms to supporttomorrow’s needs Supports consistent implementation of globally agreed study delivery and clinical development strategies including process and technology related to DM

• Operations Serving Customers: Partnering with customers as a trusted consultant and becoming an integral part of customer’s decision making Supports each clinical study and project team by ensuring data management plans and data handling activities are designed to meet project and protocol deadlines. Consults with the team(s) to ensure the teams? long-term needs are addressed. As Data Management lead to the clinical study, becomes involved in decision making processes to ensure maximum performance of the team. Provides Data Management expertise to the teams in customer oriented point of view Leads development of Data Review Plans; contributes to other key study level documents (e.g. protocols, SAPs)

• Building Authentic Relationships: Building trusting relationships that will enhance current and future needs Leads in developing trust through transparency in communication and individual actions; ensures outcomes are team driven rather than individually driven; promotes collaborative team and organizational success Key Skills, Abilities, and

Competencies:

Must be able to produce data management reports Strong attention to detail and accuracy is a must.

Ability to read, analyze and interpret complex technical documents.

Ability to present complex issues in oral and written form. Strong knowledge of MS Word, Excel, PowerPoint, Access and Outlook.

Must be able to independently present complex information to departmental management, professional organizations, CROs and the medical community.

Proven ability to manage and communicate effectively with research vendors including reviewing request for proposals, analyzing scope of work, budgeting and forecasting, responding to inquiries and complaints.

Demonstrated ability to prioritize across work assignments.

Proven ability to independently resolve problems.

Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.

Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands.

Ability to work independently, take initiative and complete tasks to deadlines.

Understanding and facility with CDISC/CDASH standards Demonstrated knowledge of data management and drug development process

May be responsible for supervising Clinical Data Management contractors.