Manager Clin Ops Management
Pharmaceutical Product Development (PPD)
Remote, New Zealand
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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.
Location/Division Specific Information
Clinical Manager oversees daily line management responsibilities of assigned team. Serves as positive leader and professional role model for respective staff, which may include Clinical Research Associates (CRAs), Country Activation Specialists (CAS), Clinical Trial Coordinators (CTCs) and/or other clinical operations focused staff. Provides direct coaching and development support to operational teams. Ultimately responsible for effective resourcing, alignment, training and on-going professional and technical development for staff. Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required. Acts as point-of-escalation regarding performance concerns and training needs to ensure adherence to the company's SOPs and sponsor requirements.Works in collaboration with the leadership team for resourcing needs.
This home-based position requires candidates to be eligible to work in New Zealand and already located in New Zealand within proximity of a well-connected air travel hub, preference for Auckland. Applicants must have a full-driving license and be willing and able to drive as part of onsite visits.
A day in the Life:
• Manages and conducts induction/orientation programs for new employees, ensuring their smooth assimilation into the company.
• Ensures all staff CVs, training records, position profiles and experience profiles are complete and up-to-date.
• Supports allocation activities per the local resourcing process. Supports activities of project leads/functional leads to optimize the operational running of projects. Escalates appropriately any issues which may impact project deliverables.
• Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact clinical operations. Identifies training gaps and ensures that training requirements are met. May contribute to development of training programs, where appropriate.
• Participates in process improvement/development initiatives.
• Ensures understanding and facilitation of the risk based monitoring approach.
• Alerts management to quality issues, requests QA audits as appropriate, and supports direct reports and project team in providing audit responses as required.
• Manages and reviews systems (e.g. CTMS, Preclarus, Clarity) to evaluate employee and project metrics, Key Performance Indicators (KPIs) and general project status.
• Evaluates work of staff, including conducting Performance Assessment Visits (either remote or on-site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable.
• Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.
Keys to Success:
Education
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Experience
Considerable clinical research monitoring experience with local knowledge that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) with a demonstrated high level of expertise in all aspects of clinical monitoring.
1+ year of leadership responsibility
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Valid New Zealand driver's license.
Knowledge, Skills, Abilities
Expert clinical monitoring skills
Expert knowledge of FDA guidelines, ICH GCPs, applicable regulations and procedural documents
Excellent critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
Proficient in Risk Based Monitoring concepts and processes
Demonstrated ability to evaluate medical research data and proficient knowledge of medical terminology
Excellent oral and written communication skills
Ability to maintain customer focus
Excellent interpersonal skills
Excellent organizational and time management skills
Strong attention to detail
Ability to remain flexible and adaptable in a wide range of scenarios
Effective presentation skills
Ability to utilize problem-solving techniques applicable to constantly evolving environment
Good digital literacy: proficient knowledge of Microsoft Office and the ability to learn appropriate software
People management and leadership
Demonstrated coaching, mentoring and training
Physical Requirements / Work Environment
Working Conditions and Environment:
Work is performed in a home office environment with exposure to electrical office equipment.
Ability to drives/fly to site locations to support Performance assessments and training of clinical operations team members. Frequent travel, generally 20-30% but more for some individuals. May also include overnight stays.
Exposure to fluctuating and/or extreme temperatures on rare occasions.
Physical Requirements:
Ability to work in an upright and /or stationary position for 6-8 hours per day.
Frequent mobility required.
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
Ability to access and use a variety of computer software.
Ability to communicate complex information and ideas so others will understand
Frequently interacts with others to obtain or relate information to diverse groups. Performs a wide range of variable tasks as dictated by demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
Regular and consistent attendance
Benefits
We offer competitive remuneration, Car allowance, annual incentive plan bonus and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Our Mission is to enable our customers to make the world healthier, cleaner and safer. 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.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Job posted: 2024-06-06
