Clinical Project Manager
Proclinical is currently recruiting for a Clinical Project Manager with a global biotechnology company located in Conshohocken, PA. Successful candidate will lead and coordinate all activities specific to assigned study or program.
- Responsible for the successful execution and oversight of assigned programs ensuring the deliverables are met with quality, timelines and budget.
- Provide oversight and accountability of all third-party vendors assigned to a program. Being a point of contact, making sure programs run in accordance with GcP and IHC.
- Lead RPF processes from proposal development through to vendor selection and contract negotiation.
- Review, negotiate and approve any required change orders.
- Management of the overall study budget, ensuring the budget stays within forecast and the approved budget.
- Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures. Ensuring knowledge is kept up to date by reading SOP's and maintaining awareness of GCP guidelines.
- Contribute to authorship of company protocol and amendment development as required. Review and approve CRFs, IRTs and other relevant specifications from a clinical perspective. Ensuring the successful support of data collection.
- Routinely review study data and progress of EDC entry; working with data management and clinical sites to resolve data discrepancies. This includes reviewing primary and secondary efficacy and safety endpoints for inconsistency, irregularities, and/or signals. Ensuring programs meet all GCP/ICH guidelines and are inspection ready.
Skills and Requirements:
- BA/BS or higher in science related field.
- Compute proficiency in MS Word, Excel, Power Point, Outlook, MS Project, SharePoint.
- Providing motivational support.
- Written and oral communication.
- Building collaborative relationships.
- Proven ability to manage multiple protocols.
- Knowledge of the oncology therapeutic discipline.
- Fully understood and applied the principles of GCP. Creating and maintaining healthy and creative relationships with study sites and principle investigators, helping to support and influence where required.
- Presented high level presentations, both orally and in writing, using organizational skills to complement this.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Natasha Patel at (+1) 617-778-7319 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.