Senior Manager, Clinical Operations

Job 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.

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 complete high-quality, cost-efficient clinical studies.

We have a vacancy for a Senior Clinical Manager for Germany. As a SrCM at Thermo Fisher Scientific you will oversee daily line management responsibilities of an assigned team and serve as positive leadership and professional role model for respective staff. This role can be office based at our sites in either Munich or Karlsruhe, Flexible Home/Office or fully Homebased in Germany. The role is permanent.

Discover Impactful Work

Manages, selects, trains, resources, coaches and performance management of respective staff, which may

be inclusive of CAS, CS, CRAs, PAs, RSMs and/or other clinical operations focused staff. Focuses on end

results using metrics and key performance indicators to manage performance. Leads or contributes to

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

Collaborates with clinical operations senior management and executive staff on strategic planning and

business development. Acts as point-of-escalation regarding performance concerns and training needs to

ensure adherence to the company's SOPs and WPDs. Works in collaboration with the leadership team for

resourcing needs.

A day in the Life:

• 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 (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.

• Provides input into bids and contribute to the procurement of new business where

required.

• Assists senior management in budgeting activity of assigned group(s) and supports

annual and long range forecasting

Qualifications

Education and Experience

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 8+

years).

2+ years of management 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, Abilities

• Excellent mentoring/leadership/supervisory skills

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

• Advanced knowledge of clinical trials monitoring; Remote and on-site

• Advanced 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

• Advanced organizational and negotiation skills

• Strong attention to detail

• Excellent written and oral communication skills

• Good knowledge of English language and grammar

• Advanced 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

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

• Advanced knowledge of medical/therapeutic areas and medical terminology

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. 

“Severely disabled applicants with the same aptitude will be given preferential treatment. / Schwerbehinderte Bewerber werden bei gleicher Eignung bevorzugt behandelt