FSP Clinical Operations Manger

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll 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 global Clinical Operations colleagues within our PPD clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out across commercial and government contracts. Together we help clients define and develop clinical programs minimize delays and execute high-quality cost-efficient clinical studies.

The PPD FSP Solution:

PPDs Functional Service Provider division partner with and serve as an extension of our PPD team supporting our customers key functions. We cover customer needs on every level allowing them to do more with less with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.

Joining within our PPD FSP functional area allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.

Summarized Purpose:

Manages selects trains resources coaches and performance management of respective staff which may be inclusive of CAS CS CRAs and/or other clinical operations focused staff. Focuses on end results using metrics and key performance indicators to manage performance. May lead or contribute to initiatives that enhance the departments performance or lead to process improvement across the company. 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 companys SOPs and WPDs. Works in collaboration with the leadership team for resourcing needs.

Essential Functions

Manages staff providing coaching mentorship and work direction.

Conducts regular performance appraisals and career discussions with staff. Facilitates employee career development. Interviews recruits and selects staff.

Manages and conducts induction/orientation programs for all 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. Ensures timeliness and accuracy of timesheets and expense reports.

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 on clinical operations. Identifies training gaps and ensures that training requirements are met. May contribute to development of training programs where appropriate.

Assures adherence to good ethical and regulatory standards.

Alerts management to quality issues request QA audits as appropriate and facilitate client and internal quality assurance audits as required.

Manages and reviews systems to evaluate employee and project metrics KPIs and general project status.

Evaluates work of staff including conducting MAST visits (either remote or on-site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable.

Participates in process improvement/development initiatives.

Ensures understanding and facilitation of the risk-based monitoring approach.

May provide input into bids and contribute to the procurement of new business where required.

Qualifications:

Education and Experience:

Bachelors degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 1-2 years).

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.

Knowledge Skills and Abilities:

Advanced mentoring/leadership/supervisory skills

Excellent clinical trials monitoring skills; Remote and on-site

Demonstrated understanding of or ability to learn the companys SOPs WPDs and relevant regulations (e.g. ICH/GCP FDA guidelines)

Demonstrated ability to evaluate medical research data

Strong organizational and negotiation skills

Strong attention to detail

Advanced written and oral communication skills

Good knowledge of English language and grammar

Demonstrated use of computer to include data entry archival and retrieval

Ability to travel as needed

Excellent team player with team building skills

Excellent interpersonal and conflict resolution skills

Advanced ability to utilize problem-solving techniques applicable to constantly changing environment

Solid knowledge of medical/therapeutic areas and medical terminology

Working 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.
• 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 requires independent travel up to 25% inclusive of traveling in automobiles airplanes and trains.

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 100000 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!