Senior Study Start-up Team Manager (remote US)
Job description
PPD, a part of Thermo Fisher Scientific, is a leading global contract research organization focused on delivering life-changing therapies. Our mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.
We have an exciting opportunity available in our Global Study Start-Up division as a Senior Start-up Team Manager (Sr. STM)! This role executes and achieves site activation deliverables (regional or globally) by managing the scope of work to timelines, costs, and quality. The Sr. STM ensures all project deliverables meet the customer’s expectations and the contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessments. This role develops and maintains strategic relationships with customers ensuring individual project targets are met, clients are satisfied, services are provided with the highest quality standards and policies and procedures are followed. No line management duties.
Essential Functions:
- Lead multiple projects or a multi-study program (regional or globally) in a matrix environment for the effective delivery of site activation.
- Oversees site activation according to timelines and quality standard.
- Leads the technical and operational aspects of site activation, including coordination of feasibility, site contracts, and country teams.
- Collaborates with functional area leads to identify and evaluate issues pertaining to a successful site activation, interpret data on complex issues, make good business decisions ensuring solutions are implemented.
- Participates with the coordination of the flow of information between PPD teams, clients, or functional departments.
- Develops plans/guidelines for project implementation using PPD tools.
- Monitors and analyzes project status to ensure successful progress and completion of all assigned projects and provide metrics to upper management.
- Performs risk identification and provides contingency planning.
- Collaborates with internal teams to manage all financial and contractual aspects of the studies related to site activation.
- Works within the Study Start Up team to establish appropriate controls to ensure that project resources and expenses are aligned with budgets.
- Identifies and escalates issues to Director/Associate Director when applicable.
- Initiates, develops, and assures execution and dissemination of study-related progress reports.
- Provides information to Country Manager regarding performance of Site Activation staff for inclusion in performance review or escalation of performance concerns.
- Utilizes problem-solving techniques within a constantly changing environment.
- Participates in risk escalation meetings as required.
- Prepares and presents materials for business development activities related to Start Up functions, with oversight from AD/Director.
- LI-NA1
- LI-Remote
Education and Experience:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
- Previous experience in clinical research (preferably site start up area) that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years’).
Knowledge, Skills and Abilities:
- Knowledge of the key principles of cross functional project management (Time, Quality, Cost).
- Demonstrated financial acumen.
- Applies a range of negotiation techniques to achieve desired outcomes with evidence of commercial and organizational acumen.
- Demonstrates effective, timely, and appropriate use of escalation pathways.
- Displays effective communication skills (listening, oral, and written) and can communicate in English language (oral, written).
- Sound interpersonal skills, is flexible and adapts to changing situations.
- Has the ability to persuade, convince, and influence others.
- Is organized, proficient at multi-tasking with good attention to detail.
- Ability to lead, motivate and coordinate teams. Coach/ mentor team members as appropriate.
- Ability to delegate, effectively prioritizes own and workload of project team members.
- Ability to identify and manage risks related to contractual deliverables.
- Ability to accurately report and analyze project specific data & systems to ensure contractual deliverables met.
- Ability to effectively use automated systems and computerized applications.
- Possesses cross cultural awareness and is able to adapt appropriately.
- In-depth understanding and appreciation of clinical research/ development, including medical and therapeutic areas, phases and medical terminology.
- Demonstrated understanding of PPD SOPs, WPDs, and relevant regulations, e.g. ICH/GCP, FDA guidelines.
Management Role:
- No management responsibility
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 require as-needed travel up to 15%, inclusive of traveling in automobiles, airplanes, and trains.
The annual salary range estimated for this position is $105,000 - $135,000. This position will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Actual compensation will be confirmed in writing at the time of offer.
We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally includes:
- A choice of national medical and dental plans, and a national vision plan
- A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HRAs) or
- Health Savings Account (HSA)
- Tax-advantaged savings and spending accounts and commuter benefits
- Employee assistance program
- At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short- and long-term disability, and volunteer time off in accordance with company policy
- Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
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