Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Associate Director CTM - FSP

Clinical Research OperationsPosted on Nov 12

Full-timeRemote in SpainNo salary listed

About the Job

Requirements

A bachelor's degree or equivalent and relevant formal academic or vocational qualification is required.
Candidates need previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 10 or more years.
Candidates need at least 5 years of management responsibility.
Candidates need proven leadership skills.
Candidates need effective mentoring, leadership, and supervisory skills; organizational and negotiation skills; and the ability to multitask.
Candidates need interpersonal skills and the ability to solve problems creatively and resolve conflicts.
Candidates need to motivate, integrate, induct, coach, and teach direct reports, and proactively manage and coach employees with performance issues.
Candidates need a record of promoting teamwork in multidisciplinary and/or multicultural teams.
Candidates need expert knowledge of clinical trials as they relate to regulations and guidelines, including ICH/GCP and FDA guidelines.
Candidates need the ability to evaluate medical research data and proficient knowledge of medical terminology and therapeutic areas.
Candidates need proficient knowledge of company practices and processes, and proficiency using company tools for project financial oversight and tools for managing timelines and data quality.
Candidates need strong attention to detail and competent use of computer and company systems to manage performance.
Candidates need the ability to synthesize and communicate complex information, and strong English language and grammar skills with effective written and oral communication.
An equivalency consisting of appropriate education, training, and/or directly related experience may be considered sufficient to meet the role requirements.

Responsibilities

Manage clinical staff and managers across several countries or a geographic area who are responsible for achieving clinical deliverables within study protocol, time, quality, and cost expectations.
Represent the department in cross-functional initiatives that enhance business objectives, as needed.
Manage staff, including interviewing and selection, preparing job descriptions, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations.
Approve courses of action concerning salary administration, hiring, corrective action, and terminations; review and approve time records, expense reports, leave requests, and overtime where applicable.
Ensure timely execution of clinical deliverables and support staff in developing and driving project and program strategies to achieve annual plans and targets.
Hold regular project review meetings with staff to identify clinical and financial project risks, ensure contingency plans and solutions are in place, and ensure appropriate and timely escalations.
Liaise with cross-functional leaders to drive clinical deliverables.
Oversee project management of clinical budgets, forecasting, and resourcing, and maintain profitability by ensuring clinical activity stays within contract scope through efficient management and guidance to staff.
Interpret and analyze complex issues and make independent business decisions.
Support staff allocation to projects through the global resourcing process and manage escalations for resourcing needs.
Evaluate out-of-scope work and assist with contract modifications as needed.
Focus workload assignments on effective project allocation, stakeholder collaboration, talent development, and staff retention through motivating and engaging actions and communications.
Manage and conduct induction and orientation programs for new employees and provide ongoing training on systems and procedures.
Ensure direct-report CVs, training records, and experience profiles are complete and up to date.
Review and ensure compliance with SOPs, WPDs, company procedure training, and other subjects that affect clinical development; contribute to developing SOPs and WPDs as needed.
Participate in cross-functional or departmental projects and initiatives as needed.
Drive immediate action and proactive escalation, including early escalation with risk solutions, effective stakeholder interaction, and quality-risk management.
Escalate quality issues, request quality assurance audits as appropriate, and facilitate client and internal quality assurance audits as required.
Provide input into bids and contribute to procuring new business where required.
Drive occasionally to site locations and travel frequently domestically and internationally.

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as Associate Director CTM – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As Associate Director CTM, you will manage a team of clinical staff and managers across several countries or a geographic area who are responsible for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time, quality, and cost expectations. You may represent the department in cross-functional initiatives that enhance business objectives.

What You’ll Do:
• 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 (if applicable).
• Ensures the timely execution of clinical deliverables with a focus on quality deliverables. Supports staff to develop and drive specific and overall project/program strategies to ensure optimum performance by achievement of annual plans and targets. Holds regular project review meetings with staff to identify potential clinical and financial project risks, ensuring contingency plans and solutions are in place, and appropriate, timely escalations are conducted.
• Liaises with cross functional leaders to drive clinical deliverables.
• Oversees the effective project management of clinical budget, forecasting and resourcing. Ensures maintenance of profitability by ensuring clinical activity is conducted within contract scope, through efficient management and guidance to staff. Interprets and analyses data on complex issues and independently make good business decisions.
• Supports the allocation of staff to projects through global resourcing process and manages escalations for resourcing needs. Evaluates out of scope work and assists with contract modifications as needed. Focuses workload assignments to ensure effective project allocation, optimize collaboration with stakeholders, cultivate talent, and promote staff retention by implementing actions and communications aimed to motivate and engage.
• Manages and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company. Provides ongoing training as needed to ensure staff mastery of systems and procedures.
• Ensures all direct report CVs, training records and experience profiles are complete and up to date.
• Reviews and ensures compliance with SOPs/WPDs/company procedure training and any other subjects that impact on clinical development. May contribute in the development of SOPs and WPDs as needed.
• May participate in cross functional / departmental projects or initiatives as needed.
• Drives a culture of immediate action and proactive escalation including early escalation to present solutions to risk, effective interaction with stakeholders, and effective management of general quality risk. Effectively escalates quality issues, requests QA audits as appropriate, and facilitates client and internal quality assurance audits as required.
• May provide input into bids and contribute to the procurement of new business where required

Education and Experience 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 (comparable to 10+ years).
• 5+ years of management responsibility
• Proven leadership skills
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:
• Excellent & effective mentoring/leadership/supervisory skills
• Effective organizational and negotiation skills; effective at multi-tasking
• Superior interpersonal skills and proven ability to be creative in problem solving and conflict resolution
• Capable of utilizing problem-solving techniques applicable to constantly changing environment
• Experienced in motivating, integrating individuals/teams, inducting, coaching and teaching direct reports
• Capable of effectively and proactively managing and coaching employees with performance issues
• Proven record to proactively direct and promote teamwork in a multi-disciplinary and/or multi-cultural team setting
• Expert knowledge of clinical trials in releveance to regulations and guidelines e.g. ICH/GCP, FDA guidelines, etc
• Excellent ability to evaluate medical research data, demonstrate proficient knowledge of medical terminology and therapeutic areas
• Proficient knowledge with company practice and processes to provide guidance and direction
• Proficient in using company tools to ensure oversight of financial management of projects for direct reports as well other tools needed to manage the timelines and quality of the data
• Strong attention to detail
• Competent use of computer and company systems to manage performance
• Strong attention to detail, ability to synthesisze and communicate complex information
• Strong knowledge of English language & grammar with effective written and oral communication skills

Working Conditions and Environment:
• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations, frequent travels both domestic and international.

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.

About the Company

Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Thermo Fisher Scientific makes and sells the instruments, chemicals, consumables and lab services that drug companies, hospitals, universities and industrial labs use for research, testing and production. Its products cover work from gene sequencing and protein analysis to diagnostic tests and lab freezers, and its distribution arm ships supplies to labs worldwide. Drug developers also hire it to run clinical trials and to manufacture medicines under contract. It earns money from consumables that labs buy again and again, along with instrument sales, service contracts and outsourcing fees. The company traces its roots to Thermo Electron, founded in 1956, which merged with Fisher Scientific in 2006, and it is based in Waltham, Massachusetts.

Company size: 10,001+
Company stage: IPO
Headquarters: Waltham, MA
Founded: 1956

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