- Title: Clinical Operations Lead
- Code: RCI-BMS-1009-1
- Location: Princeton New Jersey (NJ) 08543
- Posted Date: 10/09/2019
- Duration: 6 Months
- Name:Vishal Trivedi
- Email: email@example.com
- Phone: 908-704-8843 ✖ 435
- Provide operational oversight and leadership for the execution of an operational portfolio (Late Phase, Medical Affairs Sponsored Programs) of work (both company Sponsored and non-company Sponsored)
Key Responsibilities & Major Duties:
- Clinical operational leader who drives the successful execution of all operational components of a large-scale global program using solid project management, leadership, communication and organizational skills.
- Accountable for operational execution to support a diverse portfolio of work across company and Non-company programs.
- Addresses and manages risks and issue escalation.
- May contribute to the development of clinical operational strategy for the portfolio.
- When appropriate, develops or supports operational plan(s) with specific stakeholder’s objectives.
- Accountable for collaboration and standards of indications in line with registrational and earlier-phase development teams.
- May represent GCO Strategy organization as a core member within applicable matrix teams.
- Serves as GCO operational point of contact for the programs and respective clinical trials.
- Drives the development and/or implementation of operational program level documents.
- Inclusive in communicating strategy and decision making across a matrix team.
- Demonstrates financial stewardship of their clinical programs while effectively leading a large global team of individuals assigned to the clinical studies.
- Provides Matrix Management oversight across all operational support team(s).
List of Minimum Requirements:
- BS/BA Degree required. Advanced degree is preferred.
- Candidate must have at least 8 yrs. of experience in clinical drug development.
- Oncology experience preferred but not required.
- Leadership competencies and influencing skills with cross-functional leaders in a matrixed environment.
- Effective oral and written communication skills to influence decisions; inform and guide a large global operational team.
- Broad clinical operational experience (registration and/or post-approval) and solid project management skills.
- Ability to foster relationships across multidisciplinary teams.
- Proactive gap analysis to identify areas for training, improvement or reduce efficiencies in the operating model.
- Provides connectivity and knowledge sharing with clinical teams.
- Manages a disciplined approach that supports accurate, compliant documentation of the team’s work.
- Leads cross-functional teams to ensure successful and efficient execution of studies from start up to completion.
- Advises resource for a broad range of organizational-related issues requiring clinical knowledge and operational knowledge.
- Works with GCO functional management and across R&D to secure necessary resources to support the program needs.
- Provides input (as needed) to Health Authority or other regulatory submissions.
Operational Leadership/Decision making:
- Demonstrates an appropriate ‘sense of urgency’ to provide operational decisions in a timely manner.
- Uses judgment to make sound decisions based on a balanced evaluation of available information within a complex environment of competing project priorities.
- Acts decisively to address team challenges.
- Contributes to issue identification and strategy discussions at senior level meetings.
- Addresses the concerns and needs of stakeholders while managing stakeholders’ expectations.
- Uses judgement and seeks input (where appropriate) before making a decision.
- Demonstrates Company’s Core Behaviors and remains professional at all times.
- Facilitates issue resolution and communication/collaboration with stakeholders and other functional area team members.
- Builds alliances to gain key stakeholder support, buy-in and ownership.
- Builds and nurtures partnerships that foster an environment built upon trust.
- Provides vision to build partnerships across functional area leadership.
- Demonstrates positive attitude about the team’s ability to deal with challenges.
- Drives issues to resolution; communicates to insure that issues have been worked through to completion.
- Applies change management principles to support communication and implementation of integrated change.
- Demonstrates diplomacy when interfacing with other functional areas, CROs and other outside vendors.
- Communicates program status to different levels of stakeholders.
Development of team members:
- Provides accurate, motivating and constructive feedback and coaching to team members.
- Authentic and genuine communicator during difficult conversations.
- Invests time in getting to know others to understand their attitudes and views; learns others’ style to interact effectively.
- Accommodates cultural differences.
- Partners with functional management to set objectives for each team member to support their career development.
Software that must be used independently:
- Company’s Systems: ECLIPSE, CARA, eTMF, FastTrack (or other portal), PRISM
- Enterprise Applications: SharePoint, SAP, Microsoft Suite
- Occasional travel is required for meetings and/or training sessions. Mostly inter-site travel
- 1-2 overnights per month will require