Guidant IRC is hiring on behalf of a client for the role of a Senior Clinical Project Manager within the pharmaceutical industry.
Title: Senior Clinical Project Manager
Job Grade: GJFA 5
Department: Trial and Medical Operations (T&MO)
Reports to: Group Lead Clinical Project Management
- Location: Remote (Ireland/UK)
- Start date: ASAP
- Duration of contract: 6 months
- Rate: £420 / €480 per day
Accountable for clinical execution and management of all aspects of assigned clinical studies (interventional and non-interventional, from early phase to late phase) and other clinical services (e.g., managed access programs (MAP), Research Collaborations, IITs, Digital Solutions etc. executed by CONEXTS on behalf of the organization. Lead a global study team responsible for the planning and implementation of all operational aspects of scientifically and operationally complex studies from study concept to clinical study report/manuscript writing, according to timelines, budget, operational and quality standards (ICH/GCP/SOPs and procedures). Accountable for ongoing and effective collaboration with colleague/customers, other Line Functions, and third-party vendors. Track performance and quality aspect. CONEXTS is an internal service organization and provides clinical services to a variety of the organization’s colleagues/customers. These may range from Sr. CPM working within a colleague/customer team to Sr. CPM leading a study that has been fully outsourced to CONEXTS. Depending on the service provided by CONEXTS, the Sr. CPM may be responsible for all or part of the below listed activities or other responsibilities as deemed appropriate or activities to support business continuity.
1.Agree with colleague/customer team and Line Functions on realistic project and study timelines. Escalate to higher level in the organization if no agreement can be achieved.
2.Lead and manage a multidisciplinary cross functional Clinical Trial Team (CTT) (Medical writing, statistics, data management, monitoring partner, drug supply, regulatory, safety etc.) in the effective planning, regular re-evaluation, and implementation of assigned clinical studies and/or MAP/Research Collaborations/IITs/Digital Solutions programs according to Organizational Global processes ensuring adherence to timelines, budget, quality standards and operational procedures. Might be required to lead other projects/program, in collaboration with cross-functional teams.
3.Accountable for investigators meeting organization and all internal meetings related to the clinical study execution and operational excellence.
4.As applicable, directly Interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations, ongoing risk assessment and timely issue resolution in alignment with organizational global standard and local regulatory requirement.
5.As applicable support compilation of study regulatory documents for submissions to competent authorities and ethics-committees in collaboration with other associated CONEXTS, Organizations line functions and CRO Partners as required. Also if needed support clinical studies with all onsite/remote monitoring activities and communications with investigators, investigational sites, clinical trial team, healthcare professional and other associated internal line-functions.
6.As applicable, responsible for review of all sites visit related reports and quality control of monitoring activities in timely manner.
7.In collaboration with the CONEXTS or colleague/customer data review team. (Central data Monitors, Data Managers, Statisticians, and third parties), contribute to the study data ongoing medical/scientific data quality review to ensure high quality data are transferred/available in a timely manner.
8.Coordinate the data analysis and interpretation for first interpretable results (Where applicable) with the CONEXTS or colleague/customer Medical Representative.
9.Accountable for contributing to the development of Clinical Study Protocol, MAP treatment plan, amendments, Informed Consent Form and other study essential documents, and contributing to clinical sections of regulatory documents (Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions, review of clinical trial application packages) as required; obtain approval from colleague/customer. Responsible for Clinical Study Report either directly contributing to or managing the report writing, or by liaising with the CONEXTS or colleague/customer medical writing/narrative group to ensure report is completed according to current requirements.
10.In partnership with Clinical Operations Specialists (COS) (where applicable) accountable for the set up and maintenance of the Trial Master File (TMF), Clinical Trial Management System (CTMS) and other required systems as applicable.
11.Accountable for working with CTT and QA to identify potential issues and implementing actions to resolve them. Where applicable oversee the work of assigned Clinical Project Manager(s), Clinical Operations Specialists(s), ensuring clear delegation /assignment of duties are documented.
12.Accountable for the development, management and tracking of study budget (internal and external costs) working closely with the CONEXTS Finance and colleague/customer representative. Accountable for accuracy of study information in all study databases and tracking systems. Responsible for the preparation and presentation of the study budget to colleague/customer representatives. Ensure input is provided to clinical outsourcing specifications to facilitate bid templates and selection of vendors (e.g. central lab).
13.Execute clinical services and meet planned deliverables, in line with defined roles and responsibilities agreed with customers.
14.Lead innovation by identifying areas for process or technology improvements and participate in continuous improvement initiatives. Act as a mentor, including support the training and onboarding of new associates. Developing a continuous
process of learning and reflection and solution-orientated approach. Champion the implementation of operational changes and transitions as required.
Key Performance Indicators:
Key clinical service deliverables and milestones achieved, including appropriate resources management and accuracy in study budget management as applicable. Feedback from Key colleague/customers (Client Feedback Survey)
Ideal background and Requirements:
Relevant educational background in life sciences/Healthcare (Ideally a bachelor’s degree or above in life sciences) or equivalent combination of education, training, and experience.
Guidant IRC is acting as an Employment Business in relation to this vacancy.