PPD Associate Director, Study Start Up (remote US) in United States
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!
About the Department:
Our goal-driven teams combine and deliver startup activities for the clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations.
About the Position:
The Associate Director, Study Start-up is a line management position that provides strategic direction and creates a high performance culture through leadership, management, coaching and development to achieve delivery of site activation service targets/measures (e.g. cost, quality, time) and the effective development & implementation of systems, processes and policies for the group.
About our culture:
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
This role is responsible for the effective operations and delivery of site activation deliverables across all regions. Provides strategic direction and creates a high performance culture through leadership, management, coaching and development to achieve delivery of site activation service targets and the effective development & implementation of systems, processes and policies for the group. Fosters a culture that drives customer focused solutions, personal accountability, and delivery excellence.
- Accountable for the line management of Study Start-up Team Managers.
- Effectively recruits, inducts and retains staff. Provides ongoing coaching, feedback and training, addresses performance issues, responsible for formal performance appraisals, development plans and career coaching.
- Responsible for proposing salary and bonus recommendations and supporting recommendations with appropriate documentation
- Ensures the timely and customer-focused execution of site activation with a focus on quality deliverables
- Supports, develops and drives the overall site activation strategies to ensure optimum performance and achievement of project plans and targets
- Facilitates study start-up planning/kick-off meetings to identify potential risks and work with the project team to develop and communicate contingency plans
- Ensures project risks and potential contingencies impacting time/quality/cost of deliverables are discussed with Senior Management through appropriate escalation pathways
- Reviews and assesses team profitability through the identification of “out of scope” activity in a timely manner and supporting follow through on all aspects of contract modification
- Communicates with sponsor(s) regularly to obtain direction and feedback on implementing scope of work as well as performance to date.
- Identifies unusual or significant problems encountered during the course of a clinical trial and proposes strategies for preventing or correcting significant problems
- Assists in business development activities to obtain additional contracts by reviewing sections of proposals related to site start-up, making presentations to potential clients and representing the location/region at appropriate professional meetings and conferences
- Builds and cultivates productive relationships and internal/external networks of contacts across the global Start-up function to facilitate service delivery, client satisfaction and operational effectiveness.
- Develops and maintains strategic relationships with customers.
- Collaborates with business leads for business development, alliance management, contracts and proposals development, project management, clinical management, operational personnel, and executive management to achieve project goals.
- Ensures individual project targets are met, client satisfaction, services are provided with the highest quality standards and policies and procedures are followed.
- Contributes to and may lead change initiatives across the Clinical Development Services
Education and Experience:
Previous clinical research experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10 years) or equivalent and relevant combination of education, training, & experience.
5 years of management responsibility
Specific experience with Study Start-up activities preferred
Knowledge, Skills and Abilities:
- Strategic thinking, planning and organization skills
- Ability to analyze data, anticipate and mitigate risk, exercise sound judgment, problem solving and decision-making working under pressure and at times with limited desired information
- Ability to use personal influence and persuasion to effectively promote ideas and proposals to shape stakeholder opinions
- Demonstrates the ability to develop and cultivate strong internal/external networks of contacts and resources to help ensure operational execution
- Acts as an ambassador for change, influences and motivates, demonstrates solid interpersonal and conflict resolution skills.
- Effective negotiation and problem solving skills
- Demonstrates credible leadership style, with concise, well organized oral and written communication skills and proven ability to mobilize and foster team productivity
- Ability to motivate managers and supervisors to define and reach team objectives
- Expertise in budgeting and resource management
- Maintains a solid understanding of FDA, GCP, and ICH guidelines with a track record of successful operational delivery
- Directs through lower management levels and / or highly skilled specialist employees who exercise significant latitude and independent judgment. Often heads one or more departments or a large centralized staff function. In some instances may be responsible for a functional area (as determined by executive management) and not have subordinate supervisors or employees. May manage employees across multiple regions.
PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary for typical working hours.
- Able to work in non-traditional work environments.
- Able to use and learn standard office equipment and technology with proficiency.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
- May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.
- This role may have as-needed independent travel up to 20%, inclusive of traveling in automobiles, airplanes, and trains.
PPD Defining Principles:
We have a strong will to win - We earn our customer’s trust - We are game changers - We do the right thing - We are one PPD -
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.
Job: *Site Startup
Organization: *US BU
Title: Associate Director, Study Start Up (remote US)
Location: NC-Morrisville-Morrisville NC 3900 Paramount
Requisition ID: 202463
Other Locations: United States
PPD is an affirmative action employer that values diversity as a strength fosters and environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group