The Company
My client is an established and growing CRO located in Rockville, MD. We are looking for a few key, talented professionals to grow with us and have an impact on their own future and the future of the company. Our commitment to our clients is to be their “Partners in Success”. This means we are a team of professionals flexible enough to meet our clients’ specific needs and dedicated to helping meet their goals. We are also committed to being a performance based company with a high performing, knowledgeable and professional team. We are a diverse, entrepreneurial, employee-oriented organization that supports, motivates and rewards employees as they contribute to the company’s success. Our staff are truly our most valuable “assets”.
Role Summary:
Under limited supervision, is responsible for acting as the primary company liaison between sponsor, site, vendor, clinical staff, and internal departments to ensure adherence to study timelines and quality of all deliverables. Is responsible for overseeing and coordinating the management of all aspects of assigned global clinical projects including but not limited to preparing, negotiating and managing budgets and timelines, conducting investigator meetings, planning and executing kick-off meetings, preparing study specific SOPs and providing therapeutic training to CRAs, etc. Assist in preparing study budgets, task change orders and bid defense presentations for potential clients. Responds to questions and/or provides information upon request from clients and internal staff.
Responsibilities
- Provides leadership, direction and management on all aspects of assigned global clinical projects and leads a cross functional team to manage the study to ensure quality deliverables;
- Manage assigned project and related activities, including timelines, deliverables, study budget as well as site/vendor budgets, contracts and payments;
- Acts as a principal liaison between sponsor, investigative sites, and other study personnel and service providers; identifies any potential issues and develops mitigation plan and escalates as appropriate;
- Reviews site visit reports, protocols, clinical study reports, and any other study related documents;
- Participates in the design and review of clinical protocols, case report forms (CRFs/eCRFs), associated study documents, monitoring plans, and regulatory submissions and reports in collaboration with clinical project team; as well as prepares study specific SOPs and quality management plans and communicates them to the team;
- Plans, coordinates and conducts investigator meetings, kick off meetings, therapeutic training of CRA’s, and project specific training of CRAs; and Data Monitoring Committee (DMC) meetings, if indicated;
- Conducts weekly/bi-weekly teleconferences with sponsor, sites, and vendors; prepares agenda, provides project status updates, and reviews and finalizes minutes of the teleconferences; and tracks study progress and disseminates information to project team members;
- Oversees clinical investigational site training on protocol amendment(s), adverse event reporting, ensuring accurate and verifiable data, resolving queries, ensuring drug accountability, reviewing site study files, and ensures integrity of clinical data, etc.;
- Manages study budgets and provides monthly invoice and other information to Budgets and Contracts/Finance department within the specified timelines;
- Utilizes tact and experience-based knowledge to resolve problems (clients or staff), explaining specific policies while representing the Company in a professional manner and maintain positive client relations;
- Ensures adherence to study specific SOPs, ICH Good Clinical Practice and FDA regulations;
- Must be available for after-hours calls;
- Performs other Clinical Operations and/or administrative duties as assigned by the Director of Clinical Operations.
QUALIFICATIONS:
Education: College degree or higher in health care, a scientific field and/or in a field directly related to this position. 5 -7 years of directly related experience may be substituted for a college degree.
Experience/Skills/Knowledge:
- Minimum 3-5 years previous experience as a Project Manager. Certified Project Manager credential is preferred;
- Demonstrates working knowledge of medical/scientific terminology and knowledge of FDA regulations and ICH GCP guidelines is required;
- PC proficient including Microsoft Office (Word, Excel, Power Point, Outlook) and the Internet;
- Excellent organizational, analytical, and problem-solving skills; Must possess an exceptional attention to detail and ability to produce quality and accurate work in required timeframes;
- Ability to manage multiple projects/priorities simultaneously and produce the desired results;
- Ability to work with highly confidential information, take initiative and exercise good judgment; some degree of creativity is needed;
- Excellent verbal, written, telephone and interpersonal communications skills;
- Ability to be flexible in dealing with changing priorities;
- Ability to follow-through and react quickly to changing situations;
- Demonstrated ability to anticipate risks and consequences of current issues on future project outcomes;
- Must be a self-starter, capable of identifying needs/requirements;
- Ability to work independently and in a team setting;
- Ability to identify issues, recommend solutions and implement resolutions;
- Ability to function in a business office environment and utilize standard office equipment including but not limited to: PC, scanner, fax, copier, telephone, etc.;
- Some travel required.
GENERAL DESCRIPTION: In terms of physical requirements, this position requires work best described as:
Sedentary Light Medium. Heavy Very Heavy
PHYSICAL TASKS:
(Continuous, Frequent, Occasional or Not applicable)
- Standing/Walking/Sitting/Stooping/ Bending - Continuous
- Lifting - Able to lift up to 25 pounds (suitcases, study documents) - Occasional
- Hearing - Ability to receive information through oral communication (face to face and telephone) - Continuous
- Talking - Expressing or exchanging ideas by means of the spoken word (face to face and telephone) - Continuous
- Reading – Ability to receive information through personal computer, fax, e-mail, and text messages – Continuous
- Mobility- Ability to travel to multiple locations to discuss problems/issues and conduct orientation as needed - Occasional
AUDIO/VISUAL:
(Continuous, Frequent, Occasional or Not applicable)
- Requires vision to perform work dealing with data and figures and computer screens – Continuous
- Requires ability to prepare and execute presentations, training programs and seminars – Continuous
PSYCHOLOGICAL/MENTAL DEMANDS:
(Continuous, Frequent, Occasional or Not applicable)
- Responds positively and productively to stressful customer situations – Continuous
- Assists others to resolve problems – Continuous
Connect
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything