Company Address: Address 929 North Front Street Wilmington, NC 28401-3331

Currently, we are looking for an expert CTM 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 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

Job Qualification
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 Infectious and Respiratory Diseases: Asthma, COPD, Idiopathic Pulmonary Fibrosis, PAH, Cystic Fibrosis, HIV, COVID-19
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 Licence
Be competent 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

Apply via :

careers.ppdi.com

Job Description
PPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.
Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.
As a PPD CRA, you will perform and coordinate all aspects of the clinical monitoring and site management process.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
Summarized Purpose
Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
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 in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow 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. Conducts monitoring tasks in accordance with the approved monitoring plan. 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
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, CTMS). Performs QC check of reports generated from CTMS system where required.
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. Ensures 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.
Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc).
Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
Responds to company, client and applicable regulatory requirements/audits/inspections.
Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Contributes to other project work and initiatives for process improvement, as required.

Job Qualification
Education And Experience

Bachelor’s degree in a life sciences related field or a Registered Nursing certification 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 as a clinical research monitor).
Valid driver’s license where applicable.
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

Effective clinical monitoring skills
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
Excellent understanding and demonstrated application 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 manages Risk Based Monitoring concepts and processes
Effective 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
Effective interpersonal skills
Strong attention to detail
Effective organizational and time management skills
Ability to remain flexible and adaptable in a wide range of scenarios
Ability to work in a team or independently as required
Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software
Good English language and grammar skills
Good presentation skills

Apply via :

careers.ppdi.com