Manager - Data Management.....H1

Manager - Data Management

Responsible for managing, leading, mentoring and achieving highest utilization of assigned staff, all data deliveries for assigned projects within time and budget with highest priority applied to data quality. For planning, organisation, coordination of data management, systems, statistics and medical writing activities; for developing, maintaining and manage and meeting client expectations; overall data base consistency across all client studies within a set of project; overseas, monitors and evaluates all interactions with third party vendors; and ensures data management standards and quality are maintained and implemented across studies.

Summary of Main Job Description:

1. (10%) Managing, leading, mentoring and achieving highest utilization of assigned staff. Utilization rate should be achieved at the rate agreed with the department head.

• Provide, initiate or coordinate training necessary for the staff to be efficient and productive to complete project assignments within the time agreed with the DPMs.
• Review and assess project metrics accomplished by the staff to achieve highest quality (limited to no re-work) and productivity (tasks completed within the budgeted hours).

2. (25%) 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 – T&E) (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.

3. (35%) 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.

4. (5%) 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.

• Identify quality issues and where necessary conduct QC activities to ensure compliance to Pharm-Olam SOPs on the staff activities. Implement and monitor any remediation actions that may be necessary.

5. (5%) 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. 

6. (5%) Demonstrates Pharm-Olam core competencies at the management level; exhibits Pharm-Olam values 

7. (5%) Ensures that all project related agreements are comprehensive, accurate and complete. 

8. (10%) 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. 

Preferred Qualifications:

• Master in Science /Bachelor in Science/ RN in life sciences

Experience/Background:

• 5-8 years - MS - pharmaceutical/data managment/life sceinces
• 8-10 years - BS- pharmaceutical /data management/life sciences
• Project Management experience
• Strong Data Systems (EDC/RDBMS) experience

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