Thermo Fisher Scientific

Associate Director, CTM – FSP

Thermo Fisher Scientific

full-time

Posted on:

Location Type: Remote

Location: Serbia

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Job Level

About the role

  • 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
  • Represents the department in cross-functional initiatives that enhance business objectives
  • 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
  • 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

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
  • 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 relevance 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 synthesize and communicate complex information
  • Strong knowledge of English language & grammar with effective written and oral communication skills.
Benefits
  • Health insurance
  • 401(k) retirement plan
  • Paid time off
  • Flexible work arrangements
  • Professional development opportunities
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical trialsdata analysisfinancial managementproject managementcontract modificationSOP compliancequality assurancemedical research evaluationproblem-solving techniquesmentoring
Soft Skills
leadershipmentoringorganizational skillsnegotiation skillsinterpersonal skillsproblem solvingteamworkcoachingmulti-taskingcommunication skills
Certifications
Bachelor's degreeICH/GCP certificationFDA guidelines knowledge