Clinical Data Project Manager

**CATO SMS and Pharm-Olam, LLC have merged to form Allucent**

These customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You'll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you'll help make a positive difference in patients' lives.

**Summary**:
Responsible for all data deliveries for assigned projects within time and budget with highest priority applied to data quality. Responsible for the planning, organization, and coordination of Data Management & Data Systems, Statistics and Medical Writing activities in a set of projects belonging to one or more clients; such that quality, timelines and budget meet expectations.

Responsible for developing and maintaining Data Services Plan (DSP) to manage and meet client expectations. Responsible for overall database consistency across all client studies within a set of projects; manages all activities centered around development and maintenance of Data Management Plan (DMP), CRF design, data collection, data retrieval, coding, and query management, generation and release of TLG, and generation and release of CSR for assigned projects. Oversees, monitors, and evaluates all interactions with third party vendors; and ensures data management standards and quality are maintained and implemented across studies.

**Responsibilities**:

- Interact directly with the project ADPM/PM and the client to ensure all data delivery requirements are documented with respect to delivery specifications, timeline and quality. Ensure that all relevant parties' data expectations are aligned with the Data Services Plan.
- Oversees development and maintenance of all project related Data Management documentation & databases at Pharm-Olam, including but not limited to, Data Management Plan, Data Review Plan(DRP), Data Management Project Plan (DMPP) (to be incorporated within the overall Project Plan as appropriate), Data Quality Checks (DQC) Specification, (Point Of Entry, Level 1 and Level 2), database test and acceptance proofs, database lock and signoff forms, and archival of Data Management deliverables and documentation. Primary focus of these control documents will be to establish, maintain and deliver quality data to agreed targets reached in consensus with the project team. Oversees all project related Data Management, Statistics and Medical Writing activities, including but not limited to, CRF design, data collection, database development, implementation of DQC, consistency of data collected across investigation sites, query management, data quality control, medical coding, reconciliation between third party databases (SAE, IVRS, etc.), reconciliation between data imports (safety labs, specialty labs, etc.), quality audits of the database against DM source documents, database locks, generation, review and release of TLG, generation, review and release of CSR and archival of Data Management deliverables. Provide project metrics (quality, performance/timelines and financial) and status reports pertaining to DM, Statistics and Medical Writing activities in a timely manner.
- Ensures that a complete archive of the database and Data Management documentation and records is maintained within the TMF at the client / site in accordance with applicable client/ALLUCENT (Pharm-Olam/CATO-SMS) and regulatory guidelines.
- Demonstrates ALLUCENT (Pharm-Olam/CATO-SMS) core competencies at the management level; exhibits Pharm-Olam values.
- Ensures that all project related agreements are comprehensive, accurate and complete.
- Support Business Development (BD) in preparing and providing presentations to potential and existing clients through attendance at capabilities and/or bid defense meetings via telephone conference or personal attendance.

**Requirements**:

- Bachelor's degree and/or combination of education/experience preferred.
- 10 years of experience with data management.
- 2 years of project management experience.
- Working experience within a CRO environment.
- Strong Data Systems experience with multiple EDC/RDBMS, such asInform, Rave, Merge, and others.
- Excellent English communication skills, written and oral.
- Proficient in use of computer and software systems (Word, Excel, PowerPoint, Share Point).
- Excellent problem solving, analytical, organization, and time management skills.
- Demonstrates initiative and leadership.
- Flexible, works well in a team environment.
- Demonstrates interpersonal and negotiation skills.
- Demonstrates excellent knowledge of clinical data flow and research design.
- Strong client relationship development and management. Prior experience with kickoff and bid defense meetings are highly desired.
- This position requires up to 25% travel internationally, a passport will be required for international travel.

**Benefits**
- Comprehensive benefits package
- Competiti