Manager / Sr. Manager, Clinical Operations - FSP West Region

Job Title: Manager / Sr. Manager, Clinical Operations - FSP West Region Job Location: Remote, California, USA Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionJoin Us as Manager, Clinical Operations in FSP – Make an Impact at the Forefront of InnovationWe have successfully supported the top 50 pharmaceutical companies and more than 750 biotech's, spanning 2,700 clinical trials across 100+ countries in the last 5 years.As a Manager, Clinical Operations in FSP, you will oversee, train, resource, coach and performance manage a team, which may be inclusive of various clinical operations focused staff. You will focus on end results using metrics and key performance indicators to lead performance. You will act as point-of-escalation regarding performance concerns and training needs to ensure adherence to the company's SOPs and WPDs. You will also work in collaboration with the leadership team for resourcing needs.REMOTE position: team has a strong preference for someone on the West Coast.What You'll Do: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. Raises 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.Handles and reviews systems (e.g. Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status.Evaluates work of staff, including conducting PAVs (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.Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required.May lead or contribute to initiatives that enhance the department's performance or lead to process improvement across the company.Education and Experience Requirements:Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).1+ year of leadership responsibilityIn 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.Team has a strong preference for candidates on the West CoastKnowledge, Skills and Abilities:Advanced mentoring/leadership/supervisory skillsExcellent clinical trials monitoring skills; Remote and on-siteDemonstrated understanding of or ability to learn the company's SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines)Demonstrated ability to evaluate medical research dataStrong organizational and negotiation skillsStrong attention to detailAdvanced written and oral communication skillsGood knowledge of English language and grammarDemonstrated use of computer to include data entry, archival and retrievalAbility to travel as neededExcellent teammate with team building skillsExcellent interpersonal and conflict resolution skillsAdvanced ability to utilize problem-solving techniques applicable to constantly changing environmentSolid knowledge of medical/therapeutic areas and medical terminologyWhy Join Us?When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.Apply today to help us deliver tomorrow's breakthroughs.Compensation and BenefitsThe salary range estimated for this position based in California is $115,000.00–$178,000.00.This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:A choice of national medical and dental plans, and a national vision plan, including health incentive programsEmployee assistance and family support programs, including commuter benefits and tuition reimbursementAt least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policyRetirement and savings programs, such as our competitive 401(k) U.S. retirement savings planEmployees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discountFor more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewardsThis job is curated by Lifelancer. Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains. Please apply via Lifelancer platform to get connected to the application page and to find similar roles.

Job Title: Manager / Sr. Manager, Clinical Operations - FSP West Region

Job Title:

Job Location: Remote, California, USA

Job Location:

Job Location Type: Remote

Job Location Type:

Job Contract Type: Full-time

Job Contract Type:

Job Seniority Level:

Job Seniority Level:

Work Schedule

Work Schedule

Environmental Conditions

Environmental Conditions

Job Description

Job Description

Join Us as Manager, Clinical Operations in FSP – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotech's, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As a Manager, Clinical Operations in FSP, you will oversee, train, resource, coach and performance manage a team, which may be inclusive of various clinical operations focused staff. You will focus on end results using metrics and key performance indicators to lead performance. You will act as point-of-escalation regarding performance concerns and training needs to ensure adherence to the company's SOPs and WPDs. You will also work in collaboration with the leadership team for resourcing needs.

REMOTE position: team has a strong preference for someone on the West Coast.

What You'll Do:

• Manages staff, providing coaching, mentorship and work direction.

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.

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.

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.

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. Raises appropriately any issues which may impact project deliverables.

Supports allocation activities per the local resourcing process. Supports activities of project leads/functional leads to optimize the operational running of projects. Raises 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.

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.

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.

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

• Handles and reviews systems (e.g. Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status.

Handles and reviews systems (e.g. Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status.

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

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

• Participates in process improvement/development initiatives.

Participates in process improvement/development initiatives.

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

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.

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

• Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required.

Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required.

• May lead or contribute to initiatives that enhance the department's performance or lead to process improvement across the company.

May lead or contribute to initiatives that enhance the department's performance or lead to process improvement across the company.

Education and Experience Requirements:

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).

• 1+ year of leadership responsibility

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.

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.

• Team has a strong preference for candidates on the West Coast

Team has a strong preference for candidates on the West Coast

Knowledge, Skills and Abilities:

• Advanced mentoring/leadership/supervisory skills

Advanced mentoring/leadership/supervisory skills

• Excellent clinical trials monitoring skills; Remote and on-site

Excellent clinical trials monitoring skills; Remote and on-site

• Demonstrated understanding of or ability to learn the company's SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines)

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

• Demonstrated ability to evaluate medical research data

Demonstrated ability to evaluate medical research data

• Strong organizational and negotiation skills

Strong organizational and negotiation skills

• Strong attention to detail

Strong attention to detail

• Advanced written and oral communication skills

Advanced written and oral communication skills

• Good knowledge of English language and grammar

Good knowledge of English language and grammar

• Demonstrated use of computer to include data entry, archival and retrieval

Demonstrated use of computer to include data entry, archival and retrieval

• Ability to travel as needed

Ability to travel as needed

• Excellent teammate with team building skills

Excellent teammate with team building skills

• Excellent interpersonal and conflict resolution skills

Excellent interpersonal and conflict resolution skills

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

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

• Solid knowledge of medical/therapeutic areas and medical terminology

Solid knowledge of medical/therapeutic areas and medical terminology

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow's breakthroughs.

Compensation and Benefits

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

A choice of national medical and dental plans, and a national vision plan, including health incentive programs

A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

Employee assistance and family support programs, including commuter benefits and tuition reimbursement

Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

For more information on our benefits, please visit:https://jobs.thermofisher.com/global/en/total-rewardshttps://jobs.thermofisher.com/global/en/total-rewardshttps://jobs.thermofisher.com/global/en/total-rewardshttps://jobs.thermofisher.com/global/en/total-rewardshttps://jobs.thermofisher.com/global/en/total-rewardshttps://jobs.thermofisher.com/global/en/total-rewardshttps://jobs.thermofisher.com/global/en/total-rewardshttps://jobs.thermofisher.com/global/en/total-rewardshttps://jobs.thermofisher.com/global/en/total-rewardshttps://jobs.thermofisher.com/global/en/total-rewardshttps://jobs.thermofisher.com/global/en/total-rewardshttps://jobs.thermofisher.com/global/en/total-rewardshttps://jobs.thermofisher.com/global/en/total-rewardshttps://jobs.thermofisher.com/global/en/total-rewardshttps://jobs.thermofisher.com/global/en/total-rewardshttps://jobs.thermofisher.com/global/en/total-rewardshttps://jobs.thermofisher.com/global/en/total-rewardshttps://jobs.thermofisher.com/global/en/total-rewardshttps://jobs.thermofisher.com/global/en/total-rewards

This job is curated by Lifelancer.

This job is curated by Lifelancer.

Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

Please apply via Lifelancer platform to get connected to the application page and to find similar roles.

Please apply via Lifelancer platform to get connected to the application page and to find similar roles.