Pharm-Olam, LLC

Data Project Manager

Job Locations US-NC-Raleigh-Durham | US-TX-Houston
Job ID
2021-2945
Category
Data Managment

Overview

About Pharm-Olam, LLC:

 

Pharm-Olam, LLC is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package.

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 at Pharm-Olam, 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/Pharm-Olam site in accordance with applicable client/Pharm-Olam and regulatory guidelines.
  • Evaluates candidate third party vendors as to their ability to adhere to client/Pharm-Olam SOPs (including WPs), and quality standards before any sub-outsourcing contract is finalized in conjunction with the ADPM.
  • Demonstrates Pharm-Olam 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.

 

Working Relationships:

  • Line managed by the Associate Director of DPM (or other as appropriate).
  • Report project status to PM management/DM Management.
  • Collaborate with other Pharm-Olam DPM’s and project team members.
  • Colloborate with all departments within Pharm-Olam.
  • Collaborate with line management of project team members.
  • Liase with Sponsor staff.
  • Liase with sub-contractors.

Qualifications

 

  • 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.

 

For Consideration

 

Please apply online at www.pharm-olam.com/careers

 

Pharm-Olam, LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

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