Clinical Operations Excellence Lead, Project Management, FSP - FSP

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Clinical Operations Excellence Lead(COEL), Project Management - FSP Dedicated

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.

Discover Impactful Work :

We are seeking a Global Clinical Operations, Excellence Lead within our FSP, Project Management Team.

• This role will be hired at Senior (level depending on experience).

This role is for the North America region and is remote based.

The Clinical Operations Excellence Lead is responsible for the operational implementation of managing the quality of research & studies. This position is supporting our FSP, Project Management team. This candidate would have experience from a : Project Management or Clinical Trial Management position, with the focus in operational compliance. In addition, this person must have experience supporting Clinical Operations functions. Examples : Quality Metrics, Quality Systems, process improvements, inspection readiness, etc. The successful candidate will excel in leadership and establishing good and effective internal and external working relationships and communication.

Role Details :

Serves as the primary contact and lead between the sponsor and the organization at the project level.

Responsible for oversight & ensures standards are met Global Clinical Operations.

Responsible for commitments are met to regulatory requirements & reflected correctly in all necessary documents.

Ensure quality risk management principles are integrated in all Global Clinical Operations processes and systems in order to support compliance and ensure inspection readiness throughout

This candidate must be able to work cross functionally, ensure alignment within other business units within the organization

This candidate is responsible for driving investigations, CAPA plans, audits, inspection findings, etc.

Drives and owns the overall delivery of the cross-functional project (time, cost, quality).

Establishes, communicates and manages customer expectations to achieve optimal delivery during the project.

Drives Risk Identification and Issue Resolution

Ensures project team compliance with organization policies, SOPs, ICH- GCP, regulatory and project specific requirements.

Education

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Advanced degree (Master or PhD) in health-related discipline or equal by experience is preferred

Experience

Bachelor’s degree or University degree – medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience

Minimum of 10 years of experience in Clinical and / or Pharmacovigilance Quality Management

Working knowledge of the relationship and regulatory obligations of pharmaceutical / biotech companies and CROs

Global Strategic Drug Development experience

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.

SKILLS AND COMPETENCIES

Extensive experience of GCP / Pharmacovigilance quality management systems, applicable regulatory rules and guidelines, medical terminology, clinical trials, and drug development

Excellent interpersonal negotiation and leadership skills

Strong written and verbal communication skills, acting globally in a culturally-diverse dynamic team

Ability to act independently and effectively prioritize

Root Cause Analysis, CAPA Development and Risk Management methodology expertise

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 consultation and relationship building skills.

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.

Work Environment

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.)

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.

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.