Senior Program Manager
At Advanced Clinical, we’re excited to share with you a great opportunity at a growing organization committed to clinical excellence for the position of Senior Program Manager. The Senior Program Manager is located in Princeton, New Jersey and will act as the central contact for information on programs and managing activities to develop and commercialize programs. As they work with senior project management staff and teams to create the development strategy, establish objectives, and monitor team progress, their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity!
- Ensure that team and line management concurrence are reached on program objectives and meet the planned objectives to achieve the organization’s goals of timely and quality-focused development of new therapies and life-cycle extensions within the portfolio
- Facilitate review of development projects with Senior Management, make recommendations for action, and ensure appropriate follow-up by management to achieve approved program/project objectives
- Manage project information for assigned projects
- Develop and maintain good relationships with other project teams in order to foster positive interactions and support desired project outcomes
- Serve as development alliance liaison to support development alliance management activities based on program requirements
- Ensure smooth transitions between action points from initiating IND through product launch and full life cycle management, from early to late stage development
- Support quarterly forecasts
- Manage scope, timeline and financial changes through tracking variances at the program level
- Maintain project actions, risks, decisions and issues for project team interactions
- Support project teams toward implementation of the strategic and operational plans, then track progress to goals
- Manage and track program progress as assigned on a continual basis, identifying and tracking both cross-project and cross-functional issues, scope issues at project and program level, timeline issues, and budget issues
- Work proactively with manager and the project team to achieve timely resolution of these issues in order to achieve approved program objectives, including outsourced activities
- Ensure that timely, accurate, and comprehensive project/program information is available to senior management and the wider global organization
- Experience required in acting as the central contact for information on programs and managing activities to develop and commercialize programs
- PMP experience required
- Experience/training required in the following areas: Applicable Standard Operating Procedures, Good Clinical Practices (i.e. GxP Regulations; ICH Guidelines; Good Quality Practices), 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; 21 CFR 11 and Industry Guidance; Computerized Systems Used in Clinical Trials), HIPAA, Drug Development and Approval Process, Data Management Overview, Sponsor/Study specific trainings, and applicable system training
- Bachelor’s Degree required
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.