Sr Clinical Trial Manager

Work Schedule

Environmental Conditions

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 execute high-quality, cost-efficient clinical studies.

The PPD FSP Solution:

PPD's Functional Service Provider division partner with and serve 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. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.

Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.

Discover Impactful Work:

Take responsibility for coordinating the clinical monitoring activities, overseeing the CRO clinical /site management activities and co-monitoring the assigned international Ph 2/3 clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs to the most rigorous standards of quality, timely delivery and within budget, in order to assist in the delivery of Clinical Development objectives and achieve clinical excellence. Coordinate the achievement of assigned clinical study deliverables within a matrix organization under the leadership of the Clinical Project Managers (CPM). Be a client representative at site and build relationship with our investigators..

A day in the Life:

• Ensure clinical activities coordination & oversight

  • Ensure efficient and thorough study start-up by overseeing the Clinical team of the CROs and working closely with other relevant team members involved in the study set-up (DM, reg, CMC, etc); ensure feasibility report are exhaustive,  Review site feasibility reports as per oversight plan , support the CPM in site selection, verify timely collection of essential study documents, such as regulatory and ethics committee documents for submission, and by controlling that all set up activities are performed prior to each site initiation, as per the oversight plan.

  • Support and ensure that all specific Client/CRO EDC system tasks under the clinical responsibility are completed and achieved according to the defined timelines without jeopardising the start of a trial. Support the Clinical CRO in the training of the CRAs on all study specific operational activities and participate  in  the  organisation  and  preparation  of  the  monitor  and  investigator  meetings  in collaboration with the other study team members (Corporate and/or affiliates, CROs as appropriate) Assist the CPM/ study team in the evaluation of detailed timelines and establishment of clinical studies milestones for assigned projects, ensuring that they are performed to the most rigorous standards of quality and timely delivery.

  • Prepare and/or assist in the production of all documents necessary to oversee the clinical activity implementation, monitoring and reporting in a professional, high quality and timely manner (such as monitoring oversight plan and clin

  • Customize site Key Risk/Performance Indicator template and follow these KRIs/KPIs at frequency agreed in the oversight plan

  • Validate the final clinical study documents (such as study manual, monitoring plan, prepared by the Clinical CRO.

  • Review all/a sample of site visit reports as per the Oversight Monitoring Plan, ensuring timely and appropriate follow up of issues raised by monitors (Corporate & affiliates and/or CROs as appropriate).

  • If applicable, provide support and guidance to Internal CRAs (Client Corporate & Affiliates with provision of some supervision in specific cases).

  • Coordinate and manage the CRO relationship, assisting CRO CRAs/CTLs when and where necessary. Collaboration with the CPM in the RFP process and participation to BID defense meeting

  • If applicable to set up regular meeting with MSL (Medical Science Liaison) at LMA (Local Medical Affairs) who can support Clinical Operations at various steps (site qualification, site recruit

  • Contribute to the efficient operation of the TA Group and to transversal project cross- TAs and other departments within client (e.g. systems implementation, change management initiatives, continuous improvement initiatives

• Ensure the monitoring oversight of different activities entrusted

  • Co-monitor clinical studies according to the oversight plan, ensuring adequate contact with investigator sites, identifying and solving issues in study progress, verifying data in-house or by conducting co- monitoring visits, in collaboration with other study team members, and following up as required with CROs/CRAs/investigator.

  • Participate in  the  ongoing clinical  study  data  reviews  in  collaboration with  the  other  study  team members.

  • Make appropriate and timely reporting in CTMS,  with regular checks for quality and accuracy.

  • Ensure the agreed timelines for data collection (CRF/eCRF) and data clarifications/queries are met, sending information to data-management and monitoring CROs as appropriate.

  • Ensure that study samples/assessments flow as required per protocol is well coordinated between the various stakeholders (CROs/Vendors/client departments) from site to the central facility/specialized lab. Participate in TMF quality check review regularly to ensure adequate completion during the study course with a final thorough review at the end of the trial prior to study archiving

  • Participate in the preparation and follow-up of any other study systems (such as IWRS/IMP forecasting/flow etc, as required

  • Maintain and review key clinical documents required for Clinical Study Report (CSR), to ensure adequate quality (e.g. for CSR appendices publishing)

  • As appropriate, participate in the preparation of study documents and perform site visits prior to audits /inspection and assist in audit follow-up /findings resolution.

  • Be a client ambassador at site and create relationship with our Investigators

  • Perform various study related functions to ensure the execution of clinical studies such as: act as site CRA as directed by line manager act as back up of the CPM when requested

Complete all of the above activities within the framework and in compliance with client Global SOPs and other documentation in force within the client group.

• Clinical activities (out of studies)

  • Contribute/participate  on  SOP  update  and  review  training  material  created  by  Process  Training Management

  • Contribute to the efficient operation of the TA Group and to transversal project cross- TAs and other departments within client (e.g. systems implementation, change management initiatives, continuous improvement initiatives

• EHS Responsibilities

  • Comply with applicable EHS regulations and procedures.

  • Participate in the site's EHS performance by reporting risks, malfunctions or improvements

  • Participate in mandatory EHS training

Keys to Success:
 

Education

• Life science or medical graduate or other relevant qualifications.

• Minimum: CRA graduated

Experience

• Experience of minimum 1 year (ideally 2 years) of Lead CRA e.g. coordination of clinical activities/site management activities for the set up and running of international registrational studies (multiple sites/countries).

• Experience as a Field CRA monitor for at least 3 years (CROs or Pharma Industry)

• Excellent Knowledge of Good Clinical Practice (GCP), ICH regulations.

• Experience in preparing clinical study documentation for study set up, maintenance and closing

• Experience in managing and developing relationships with Contract Research Organizations (CROs). Global studies (multiple countries/sites) experience

• Previous experience in the Therapeutic area of studies (Neuroscience, Oncology or radiopharmaceutical compound) is a plus

Knowledge, Skills, Abilities

• Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams

• Good planning and organizational skills to enable effective prioritization of workload

• Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization

• Capable of working effectively in a changing environment with complex/ambiguous situations

• Familiarity with the practices, processes, and requirements of clinical monitoring

• Good judgment and decision making skills

• Effective oral and written communication skills, including English language proficiency

• Capable of evaluating workload against project budget and adjusting resources accordingly

• Sound financial acumen and knowledge of budgeting, forecasting and fiscal management

• Strong attention to detail

• Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.

• Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc

Working Environment

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

• Able to work upright and stationary for typical working hours.

• Ability to use and learn standard office equipment and technology with proficiency.

• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

• May require travel. (Recruiter will provide more details.)

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. 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. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
 

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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
 

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