Lediga jobb Ppd Scandinavia AB i Sundbyberg

At PPD, part of 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.


This is a great opportunity for CRA's currently working within the life science sector for pharmaceutical companies, biotech companies or CRO's to work with a world-leading CRO across multiple sponsors, various protocols and therapy areas.


Essential Functions:
Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
Assess investigational product through physical inventory and records review.
Documents observations in reports and letters according to timelines using approved business writing standards.
Escalates observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members.
Contributes to other project work and initiatives for process improvement, as required.
Education and Experience:
University degree in a science related field
Understanding of ICH-GCP, EU and FDA requirements
Fluency in English
Knowledge, Skills and Abilities:
Proven clinical monitoring skills
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
Ability to manage Risk Based Monitoring concepts and processes
Good oral and written communication skills, with the ability to communicate effectively with medical personnel
Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues
Good organizational and time management skills
Effective interpersonal skills
Attention to detail
Ability to remain flexible and adaptable in a wide range of scenarios
Ability to work in a team or independently as require
Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
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 organization 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 world's most urgent health needs, submit your application – we'd love to hear from you! Visa mindre

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 goal-driven teams combine and deliver start-up activities for the clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease start-up timelines and exceed expectations.?
We are currently recruiting for a Senior Start-Up Team Manager to join our team in EMEA, working remotely. The Senior Start-Up Team Manager develops and maintains strategic relationships with customers, executes and achieves site activation deliverables within assigned projects or programs and ensures all project deliverables, meet customer expectations and contracted deliverables. The Sr STM will provide accurate projections, report updates, and ongoing risk assessments and collaborates with PPD clinical research services teams to manage all financial and contractual aspects of the studies related to site activation. You will also coordinate feasibility, site contracts, and country teams in a matrix environment and manage the assigned scope of work against timelines, costs, and quality.
Qualifications
To be considered for the role of Senior Start-Up Team Manager you should have the following qualifications 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 10+ years')
Demonstrated ability to lead, liaise and coordinate cross-functional project teams
Demonstrated knowledge and experience of cross functional project management
Demonstrated attention to detail, organizational and multitasking skills
Demonstrated solid financial acumen
Ability to accurately report and analyze project specific data & systems to ensure contractual deliverables met
Ability to effectively use automated systems and computerized applications
Demonstrated understanding of PPD Clinical Research Services' SOPs, WPDs, and relevant regulations, e.g. ICH/GCP, FDA guidelines
Ability to identify and remedy risks related to contractual deliverables and provides solutions
Comprehensive understanding and appreciation of clinical research/development including medical and therapeutic areas, phases and medical terminology
Understanding of cross-cultural awareness and can adapt appropriately
Ability to lead and manage multinational Start up teams across different regions (North America, Latin America, Asia Pacific, Europe, Middle East and Africa) which includes a comprehensive understanding of general regulatory process for different countries.
Fluence in English

At PPD Clinical Research Services we hire the best, develop ourselves and each other, and recognize 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.??
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
*only shortlisted candidates will be contacted
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. Visa mindre