Clinical Team Lead

hace 6 meses

Madrid, España TFS HealthScience A tiempo completo

Overview:
**International Clinical Team Lead - Clinical Trial Lead - Senior Project Manager**

TFS HealthScience is excited to be expanding our SRS
** **team and we are looking for an experienced, highly motivated
**Clinical Trial Lead **who shares our vision of providing clinical research excellence. Our
**SRS** team is a highly experienced international group of professionals led by an industry expert.

We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.

Our cores values of Trust, Quality, Flexibility and Passion are what makes TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organisation.

**Together we make a difference.**

TFS HealthScience is looking for a Clinical trial lead hybrid model (1/2 days working from the office) in Madrid/Barcelona

**What can we offer you?**

A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients.

**Benefits include**:
Health insurance

Ticket restaurant

Home allowance

Flexible remuneration

**Responsibilities**:
The clinical trial lead is accountable for the set-up, execution and delivery of the assigned trial(s) and leads the trial team and Clinical Trial Managers of participating countries. Also, CTL is responsible for managing the planning, implementation and tracking of the Clinical trial processes as well as risk mitigation.
- Leads development and implementation of trial documents as protocol, engagement plans, core trial and patient facing documents. Support development of trial level documents by other functions (i.e., statistics, data management).
- Accurate planning and operational feasibility of trial timelines. Oversight of trial preparation to ensure trial team members are aligned and on track.
- Prepares and reviews study budget with all study related stakeholders.
- Oversight outsourcing of vendor services in conjunction with other functions. Support vendor selection.
- Align and support trial team members in timely responses to questions from regulatory authority and EECC
- Oversight during clinical trial including adherence to GCP and global and local regulatory requirements, compliance with SOPs and continuous risk monitoring/mitigation. In collaboration with other functions, assures budget oversight, safety reporting, trial committees and clinical quality monitoring.
- Participate in working groups as the CTL network.
- Fulfillment of data Management requirements for data cleaning, close out and reporting activities. Prepare audits/inspections.
- Coordinate and support Trial Medical Writer in providing the CTR. Responsible for complete archiving of study documents and trial disclosure.

(Such list is illustrative of the main services and tasks shall manage but is not a closed list). Qualifications:
Degree in Life Sciences. ICH, GCP.

Between 5-10 years of experience working as a Clinical Project Manager, at least 2 leading clinical teams

International experience
- TFS HealthScience collects and processes personal data in accordance with applicable data protection laws. If you are a European Job Applicant see the _
- privacy notice_
- for further details._
- TFS HealthScience does not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits._

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