Senior Clinical Team Manager - Neuroscience - Serbia/Bulgaria

Our Project Delivery team advises, coordinates and leads the technical and operational aspects of projects, securing the successful completion of clinical trials. The team is therapeutically aligned to respond better to our customer needs. The therapeutic scope includes: General Medicine, Hematology/Oncology, Infectious, Respiratory & Critical Care Diseases Neuroscience and Vaccines.

Currently, we are looking for an expert Clinical Team Manager to join our team. This exciting and unique role could take you the next step of your career within Clinical Research. As a Clinical Team Manager (CTM), you combine deep knowledge, therapeutic expertise, and robust tools to help our clients deliver life-changing therapies to market. You take ownership, anticipate problems, find solutions and deliver results

The role coordinates all aspects of clinical activities on an international basis, including:

• Day to day management and leadership of a team of Clinical Operations members who are allocated to a project on a Country basis
• Responsibility for the achievement of the project clinical deliverables within the contractual timelines and budget
• Development of clinical tools (e.g. Monitoring Plan and Guidelines) and set up of the required training, tracking and quality systems
• Work in partnership with the Project Manager to prepare, organize, and present at client meetings, including bid defense and kick off meetings
• Clinical Resource Management - provide input into preparation of forecast estimates of clinical deliverables, assignments and identification of additional resource requirements
• Acting as a contact and support to the Sponsor for all clinical-related aspects of the project

Does this sound like you? If so, you need to have:

• Bachelor's degree or licensed certified health care training or equivalent combination of education and experience
• Previous cross-country CTM/ Project Management experience in excess of 2 year, including specific knowledge for Neuroscience: CNS, Neurodegenerative diseases (Alzheimer's disease, Parkinson's disease), rare diseases (Duchenne muscular dystrophy, ALS, Fragile X), Ophthalmology, Psychiatry
• Gene therapy experience would be considered as an advantage
• Clinical research experience in all phases of study life cycle, including start up, interim and close out
• Study finance management experience
• Ability and willingness to cross-region and in region travel according to the project needs
• Valid Passport and Driving License
• Be proficient in use of written and oral English language

Knowledge, Skills and Abilities:

• Outstanding organizational skills
• Critical thinking skills
• Proven performance management abilities
• Excellent judgment and decision-making skills
• Highly effective verbal and written communication and presentation skills
• Experienced knowledge of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
• Experience in Rare Diseases/ALS/Ophthalmology or Psychiatry

We will consider applications from Bulgaria, Serbia & UK

Closing date for internal applications: 8th May 2024

At PPD Clinical Research Services we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.

Our 4i values Integrity - Innovation - Intensity - Involvement

If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the word's most urgent health needs, submit your application - we'd love to hear from you!

As we are likely to receive many applications, sometimes we are unable to provide feedback to everyone.

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 Project Delivery team advises, coordinates and leads the technical and operational aspects of projects, securing the successful completion of clinical trials. The team is therapeutically aligned to respond better to our customer needs. The therapeutic scope includes: General Medicine, Hematology/Oncology, Infectious and Respiratory Diseases, Cardiovascular/Metabolic/Critical Care, Neuroscience and Vaccines.

Currently, we are looking for an expert Clinical Team Manager to join our team. This exciting and unique role could take you the next step of your career within Clinical Research. As a Clinical Team Manager (CTM), you combine deep knowledge, therapeutic expertise, and robust tools to help our clients deliver life-changing therapies to market. You take ownership, anticipate problems, find solutions and deliver results

The role coordinates all aspects of clinical activities on an international basis, including:

• Day to day management and leadership of a team of Clinical Operations members who are allocated to a project on a Country basis
• Responsibility for the achievement of the project clinical deliverables within the contractual timelines and budget
• Development of clinical tools (e.g. Monitoring Plan and Guidelines) and set up of the required training, tracking and quality systems
• Work in partnership with the Project Manager to prepare, organize, and present at client meetings, including bid defense and kick off meetings
• Clinical Resource Management - provide input into preparation of forecast estimates of clinical deliverables, assignments and identification of additional resource requirements
• Acting as a contact and support to the Sponsor for all clinical-related aspects of the project

Does this sound like you? If so, you need to have:

• Bachelor's degree or licensed certified health care training or equivalent combination of education and experience
• Previous cross-country CTM/ Project Management experience in excess of 2 year, including specific knowledge for Neuroscience: CNS, Neurodegenerative diseases (Alzheimer's disease, Parkinson's disease), rare diseases (Duchenne muscular dystrophy, ALS, Fragile X), Ophthalmology, Psychiatry
• Gene therapy experience would be considered as an advantage
• Clinical research experience in all phases of study life cycle, including start up, interim and close out
• Study finance management experience
• Ability and willingness to cross-region and in region travel according to the project needs
• Valid Passport and Driving License
• Be proficient in use of written and oral English language

Knowledge, Skills and Abilities:

• Outstanding organizational skills
• Critical thinking skills
• Proven performance management abilities
• Excellent judgment and decision-making skills
• Highly effective verbal and written communication and presentation skills
• Experienced knowledge of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.

The position is opened in Bulgaria only for office or home-based employees.

At PPD Clinical Research Services we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.

Our 4i values Integrity - Innovation - Intensity - Involvement

If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the word's most urgent health needs, submit your application - we'd love to hear from you!

As we are likely to receive many applications, sometimes we are unable to provide feedback to everyone.