- Serves as the primary contact and lead between the sponsor and the organization at the project level.
- On projects where the scope requires, ensures clear delineation in responsibilities and communication pathways for secondary project leads (such as lead in a specific region, lead for a specific vendor(s) or subset of delivery).
- Drives and owns the overall delivery of the cross-functional project (time, cost, quality).
- Ensures financial stewardship at a project level by demonstrating an intimate understanding of the contract, resource alignment to budget, management of Out of Scope activity, drive the Con Mod process/negotiations and team execution to timelines.
- Establishes, communicates and manages customer expectations to achieve optimal delivery during the project.
- Ensures project team compliance with organization policies, SOPs, ICH- GCP, regulatory and project specific requirements.
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job
- _Project Manager role:
- _Senior Project Manager:
- Proven leadership skills
- Experience in management of:
- Documented training, knowledge and application of current FDA/EU Regulations, GCP & ICH guidelines for patient registries and studies
- Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or
- making employment selection decisions.
- Comprehensive therapeutic area knowledge, clinical development guidelines and directives and regulatory guidelines .
- Expert knowledge of the key principles of cross functional project management (Time, Quality, Cost).
- Excellent oral and written communication and presentation skills.
- Demonstrated leadership and interpersonal skills including the ability to lead, motivate and coordinate cross-functional project teams.
- Technical and systems competency, such as computer skills, to include effective use of systems and applications such as Microsoft Outlook, Word, Excel and PowerPoint, as well as organization systems (CTMS, Preclarus, Clarity).
- Proven flexibility and ability to effectively prioritize workload and resources for project team members in a frequently changing environment.
- Skilled in process improvement and strategic development, especially as it applies to clinical trials, clinical development and project management.
- Ability to coach, mentor and lead global and/or cross-functional teams with a cultural awareness.
- Strong financial acumen with an in-depth of knowledge and practical application of budgeting, forecasting and resource management.
- Excellent customer service, consultation and relationship building skills.
- Advanced negotiation and marketing skills with ability to influence others and drive results.
- Excellent judgment, decision making and problem-solving skills and proven ability to apply critical and analytical strategic thinking skills to manage complex/ambiguous situations.
- Proactive, solutions oriented and skilled at risk identification and management.
- Proficient written and verbal communication skills
- Ability to collaborate effectively with the study team, cross functional team members and external partners (including investigator and site staff) using collaborative negotiation skills
- Therapeutic or medical knowledge preferred
- Strong computer skills including knowledge of Excel, Word, PowerPoint and Outlook
- Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.
- 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.
- Ability 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 require travel. (Recruiter will provide more details.)
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Senior Project Manager/ Project Manager: FSP Dedicated Team - Greenville, United States - Thermo Fisher Scientific
Description
Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale.
Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer.
We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.
With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.
Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Our Project Delivery colleagues within our PPD clinical research services direct, coordinate and manage the technical and operational aspects of projects, securing the successful completion of clinical trials.
This includes collaborating with functional area leads to identify and evaluate fundamental issues on the project and to ensure that solutions are implemented.
Project Delivery is vital to helping our customers deliver life-changing therapies.Role:
Senior Project Manager OR Project Manager
Location:
Remote, Homebased, North America
Discover Impactful Work:
We are seeking a Project Manager/Lead in within our Functional Service Provider Team. This role will be hired at Project Manager OR Senior Project Manager level depending on experience). This role is for the North America region and is remote based.
The PL Is accountable for the overall delivery of the project (quality, time, cost) on behalf of the organization.
This individual manages all aspects of assigned clinical trials as well as the study project plan, including timeline, budget, and vendors.
Establishes and communicates customer expectations to the project team with minimal direction. Ensures that escalation pathways are adhered to internally and externally. Leads the cross-functional project team to meet or exceed deliverables. Manages project(s) of increasing complexity (such as but not limited to: multi-service, multi-region/country, therapeutic complexity, financial scope).A day in the Life:
Keys to Success:
Education
_ Minimum of 6+ years' experience in clinical research with at least 4 years' experience in study management with strong experience with study phases I-IV, global trials, and with complex trial designs.
Rare disease study management is recommendedAs one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.
#StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
