Associate Director, Data Management

2 weeks ago

Woburn, United States Replimune, Inc. Full time

Overview:
**Summary of job description**:
The Associate Director, Data Management (DM), is responsible for the oversight of DM activities related to the planning and timely delivery of complete, high quality and reliable clinical trial data.

The Associate Director, DM will provide oversight to ensure data management process consistency across the portfolio. The employee will also provide input to Replimune clinical drug development programs to ensure data management best practice adherence. **The employee may act as Sponsor-level lead data manager for one or more trials.** As a data manager, the employee will be responsible for carrying out or overseeing trial related data management activities including planning, data collection, data cleaning and participate in other trial related activities.

The Associate Director, DM will lead/support various initiatives/activities within the department or across departments, in alignment with ICH-GCP, internal SOPs and guidelines. This includes, but is not limited to, writing and contributing to Replimune SOPs, procedures and guidelines within Clinical Operations and across functional areas.

This position can be based either in our **Woburn office or be a remote role**

**Responsibilities**:
**Key responsibilities**:

- Contributes to the overall strategy and areas for development of DM
- Ensures DM activities and processes support the efficient and effective execution of clinical trials
- Drives development of systems and processes within DM
- Ensures DM process consistency and transparency across the portfolio
- Proactively engages in department activities
- Arranges lessons learned meetings both internal and with vendors
- Leads various initiatives within the department and across departments
- Acts as mentor for junior/new employees or consultants

**Other Responsibilities**:

- Supports the development of DM partnership relationships and effective collaboration with CROs/Vendors
- Ensures DM operational excellence and implementation of best practices
- Ensures alignment of processes between vendor and Replimune SOPs
- Leads routine meetings with Replimune DMs to ensure consistency and communication of issues across trials
- Ensures trial related data management activities (including planning, data collection, data cleaning and database lock activities) are performed in accordance with Replimune and study-specific SOP/processes and standards and ICH-GCP
- Provides oversight of DM CRO including Statement of Work, budget, KPIs, and performs other DM CRO oversight activities.

Qualifications:
**Educational Requirements**:

- Bachelor’s degree in scientific/technical discipline is preferred

**Experience and Skill Requirements**
- Planning and organization
- Clinical development/trial conduct, including ICH-GCP
- Leadership across multiple data managers and Protocols
- Problem solving and decision making
- Good Communication skills and able to communicate scientific communication in clear and concise manner
- Communication
- Quality mindset
- Document creation and management
- Process development
- Proactive and Accountable
- Analytical and ability to interpret and present clinical data
- IT skills

**Location**:

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