Manager/Sr Manager Clinical Operations

il y a 3 semaines

Bruxelles, Région de Bruxelles, Belgique Thermo Fisher Scientific Temps plein

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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. 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:

PPD's Functional Service Provider division partners with and serves 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.

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, PAs, RSMs 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 department's performance or lead to process improvement across the company. Acts as point-of-escalation regarding performance concerns and training needs to ensure adherence to the company's SOPs and WPDs.

Essential Functions

  1. Manages staff, providing coaching, mentorship and work direction.
  2. Conducts regular performance appraisals and career discussions with staff. Facilitates employee career development. Interviews, recruits and selects staff.
  3. Manages and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company.
  4. 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.
  5. Supports allocation activities per the local resourcing process. Supports activities of project leads/functional leads to optimize the operational running of projects.
  6. 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.
  7. Assures adherence to good ethical and regulatory standards.
  8. Alerts management to quality issues, requests QA audits as appropriate, and facilitates client and internal quality assurance audits as required.
  9. Manages and reviews systems (e.g. Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status.
  10. Evaluates work of staff, including conducting PAVs (either remote or on-site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable.
  11. Participates in process improvement/development initiatives.
  12. Ensures understanding and facilitation of the risk based monitoring approach.
  13. May provide input into bids and contribute to the procurement of new business where required.

Policy & Strategy

Interprets and administers policies, processes, and procedures that may affect sections and subordinate work units. Requires full knowledge of own area of functional responsibility.

Freedom to Act

Assignments are defined in terms of activities and objectives. Work is reviewed upon completion for adequacy in meeting objectives.

Liaison

Interacts frequently with internal personnel and outside representatives at various levels. Participates and presents at meetings with internal and external representatives. Interaction typically concerns resolution of operational and scheduling issues.

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 5+ 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:

  1. Advanced mentoring/leadership/supervisory skills.
  2. Excellent clinical trials monitoring skills; Remote and on-site.
  3. Demonstrated understanding of or ability to learn the company's SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines).
  4. Demonstrated ability to evaluate medical research data.
  5. Strong organizational and negotiation skills.
  6. Strong attention to detail.
  7. Advanced written and oral communication skills.
  8. Good knowledge of English language and grammar.
  9. Demonstrated use of computer to include data entry, archival and retrieval.
  10. Ability to travel as needed.
  11. Excellent team player with team building skills.
  12. Excellent interpersonal and conflict resolution skills.
  13. Advanced ability to utilize problem-solving techniques applicable to constantly changing environment.
  14. Solid knowledge of medical/therapeutic areas and medical terminology.

Management Role:

Manages experienced professionals and/or subordinate management who exercise latitude and independence in their assignments. Often heads one or more sections or a small department.

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