- 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: Minimum of 3-5 years' experience in clinical research with at least 1-2 years' experience in study management preferred
- Senior Project Manager: 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 recommended
- Proven leadership skills
- Experience in management of: CROs, vendors and consultants
- 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. 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.
- 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.)
-
Employee in Material Management
2 weeks ago
Stellar Ventures Carolina, United StatesDATAGROUP in Hamburg is one of the leading German IT service providers - thanks to our dedicated team. Our passion for technology and innovation allows us to deliver reliable IT services to our customers. Join us for an exciting and challenging role in an innovative company. Our ...
-
Senior physician for gynecology and obstetrics
2 weeks ago
Cascade Ventures Richland, United StatesRichland is currently seeking a Senior Physician in Gynecology and Obstetrics (m/f/d) and a Specialist in Gynecology and Obstetrics (m/f/d) for our Eichsfeld Clinic, which includes two hospital locations and two subsidiary companies, EK Pflege and EK Praxis. As the largest employ ...
-
CNC Machinist
2 weeks ago
SilverLinx Carolina, United StatesWe are Trio Personnel Management - your regional staffing agency. Our entire management team, as well as our employees, have many years of experience in temporary staffing, recruitment, sales, customer service, recruiting, and employee care. We are dedicated to our work and have ...
-
Adjuster for production facilities
2 weeks ago
Titan Ventures Columbia, United StatesYour responsibilities: · - Setting up and operating confectionery machines and film extrusion systems · - Identifying and resolving malfunctions · - Conducting quality assurance measures · - Approving production orders · - Technically optimizing existing systems · Your profile: · ...
-
Plant mechanic
2 weeks ago
SilverTech Columbia, United StatesAs a dynamic addition to our existing team, SPIE SAG GmbH, a specialist in energy infrastructure in the CityNetworks & Grids division, is looking for you as a/an · Plant Mechanic / Industrial Mechanic / Installer m/f/dWe offer:Employment in a crisis-proof, growing company with a ...
-
KI-Architect (male/female/diverse)
2 weeks ago
Nebula Technologies Richland, United StatesWe are looking for a dedicated and experienced AI architect (m/f/d) to join our team and significantly contribute to the expansion of our X4 BPMS platform. By using AI technologies, business processes are digitized faster and easier, and processes are analyzed to make them more e ...
-
Join our team as a receptionist
2 weeks ago
Titan Ventures Richland, United StatesThe Medical Park Group is a nationwide leader in quality rehabilitation and an employer for over 3,650 employees. Our group includes 13 specialist clinics and five outpatient therapy and rehabilitation centers. · At our outpatient rehabilitation center, Medical Park alpha-Reha Fü ...
-
Work time manager
2 weeks ago
Emerald Enterprises Richland, United StatesThe Evangelical Hospital Königin Elisabeth Herzberge stands for health in Berlin Lichtenberg: · In 15 specialist departments and 5 day clinics, we offer first-class medical care. As a teaching hospital of the Charité and part of the von Bodelschwingh Foundations Bethel, we employ ...
-
Butcher / Meat Sales Fresh Counter (m/f/d)
2 weeks ago
Aurora Ventures Columbia, United StatesLocation: 54292 Trier | Contract type: Full-time/Part-time, permanent | Job ID: 824308 · What you'll be doing with us: · The fresh food counter is the heart of our REWE Tim Schirra oHG. Here, you'll share your passion for meat, sausage, and cheese and advise our customers with yo ...
-
Horizon Ventures Richland, United StatesRichland University of Europe for Applied Sciences (UE) is dedicated to providing students from all over the world with a top-quality education. We offer our programs in English and/or German and are proud to have one of the most diverse student bodies in Europe. Our campuses in ...
-
Vehicle Painter
2 weeks ago
BlueWave Solutions Forest Acres, United StatesJOB DESCRIPTION · We, THE WORKSHOP MERTENS, are a family-owned business with currently 30 employees. Founded in 1998, our top priority has always been to provide our customers with the perfect and most cost-effective solutions in all areas of automotive repair. With our many year ...
-
PT Customer Experience Manager
1 week ago
Michaels Columbia, United States Temps partielStore - COL-HARBISON, SCQue ferez-vous? · Offrir une expérience de magasinage centrée sur la clientèle en gérant et en · obtenant une exploitation de l'aire des caisses efficace et en respectant les attentes. · Diriger les processus omnicanaux. Maintenir les normes de rangement ...
-
Travel ICU
1 week ago
Medical Solutions Columbia, United States$ $2033.9 wk (includes wage of ~$18.63-$24.22/hr and per diems if eligible) · click for benefits and other job details · ~$670.52-$871.9 weekly taxable income · ~$1162 in non-taxable per diem (amount subject to eligibility & seasonal/annual adjustment) · Are you ready to choose y ...
-
Travel ER
1 week ago
Medical Solutions Columbia, United States$ $ wk (includes wage of ~$17.25-$19.79/hr and per diems if eligible) · click for benefits and other job details · ~$621-$712.36 weekly taxable income · ~$ in non-taxable per diem (amount subject to eligibility & seasonal/annual adjustment) · Calling all healthcare rockstars Are ...
-
Housekeeper
2 weeks ago
Agape Care Group Capitol, United States PermanentOverview: Join Our Team as a Housekeeper · Do you have a heart for creating positive patient experiences? Are you committed to creating a clean and comfortable environment for patients and their families? We are looking for housekeepers who are dedicated to creating meaningful pa ...
-
Travel ER
1 week ago
Medical Solutions Columbia, United States$ $ wk (includes wage of ~$17.25-$19.79/hr and per diems if eligible) · click for benefits and other job details · ~$621-$712.36 weekly taxable income · ~$ in non-taxable per diem (amount subject to eligibility & seasonal/annual adjustment) · Take control of your career with this ...
-
pharmacist - 2nd shift
3 days ago
BrightSpring Health Services Columbia, United States Full timeOverview · Our Pharmacy group focuses on providing exceptional customer service and meeting the pharmacy needs for hospitals, rehabilitation hospitals, long-term acute care hospitals, and other specialized care centers nationwide. If your passion is service excellence and top-qu ...
-
Travel Nurse
45 minutes ago
Medical Solutions Columbia, United StatesMedical Solutions is seeking an experienced Medical Surgical Registered Nurse for an exciting Travel Nursing job in Columbia, MO. Shift: 3x12 hr nights Start Date: 07/08/2024 Duration: 13 weeks Pay: $ / Week $ $ wk (includes wage of ~$19.59-$25.29/hr and per diems if eligible) · ...
-
Dentist
23 hours ago
Oakpoint Columbia, United States Full timeJob Summary: · Are you a passionate and skilled dentist looking to join a thriving dental practice in the heart of Columbia, South Carolina? West Vista Dental is excited to announce an opening for an Associate Dentist to join our dedicated team. As a well-established and patient ...
-
Travel Nurse
3 days ago
Medical Solutions Columbia, United StatesMedical Solutions is seeking an experienced Medical Surgical Registered Nurse for an exciting Travel Nursing job in Columbia, MO. Shift: 3x12 hr nights Start Date: ASAP Duration: 13 weeks Pay: $1979.5 / Week $ $1979.5 wk (includes wage of ~$17.26-$22.71/hr and per diems if eligi ...
R-01240282 Senior Project Manager/ Project Manager: FSP Dedicated Team - North Carolina, United States - Thermo Fisher Scientific
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
Experience
Knowledge, Skills, Abilities
Work Environment
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As 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.
