At Enterin, we are pioneering the medical community’s understanding of the link between infections, dysfunction of the enteric nervous system (ENS) of the gut, and the early onset and chronic progression of neurodegenerative disease.
To apply for any of the career opportunities shown below, please send your resume and an optional cover letter to email@example.com. Please note in the Subject line for which position you are applying. We will try to respond to each applicant within a reasonable period of time, although please recognize that depending on the volume of applications, we may not be able to respond to each applicant. Thank you for your understanding and for your interest in working at Enterin.
Enterin is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Enterin does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Enterin from recruiters do not constitute any type of relationship between the recruiter and Enterin and do not obligate Enterin to pay fees if we hire from those resumes.
The Clinical Trial Manager will direct and coordinate the operational and logistical activities necessary for the initiation and completion of clinical trials on time and on budget
- Responsible for managing activities associated with the conduct of assigned clinical trials.
- Develop and assist with protocols, consent forms, monitoring plans, case report forms, and other clinical documents related to clinical trials.
- Manage investigational sites and/or CROs to ensure compliance with protocol and overall clinical objectives; including traveling to sites to conduct pre-study, initiation, interim and closeout visits and/or co-monitor with CRO or contract associates.
- Negotiate contracts and budgets with clinical investigational sites and other vendors.
- Supervise clinical site monitors (internal and/or contract).
- Select and manage CROs and other consultants and vendors to ensure adherence to domestic and international regulations and standards (GCP and ICH).
- Participate in the review and update of existing procedures and develop new procedures as needed.
- Develop and maintain clinical project timelines.
- Interface with other departments within the organization to exchange technical data and negotiate courses of action on behalf of Clinical Operations.
- Lead study team meetings and update project management on a weekly basis of study timelines and activities.
- Perform other related duties as required to support Clinical Operations and Enterin.
- BS or equivalent experience in a scientific or medical discipline with 5 -10 years clinical trials management experience.
- Experience managing external suppliers and/or working in a virtual environment (e.g., CROs and independent contractors)
- Previous management or project management experience with demonstrated leadership ability.
- Excellent communication; interpersonal skills and influencing skills
- Ability to determine the people, funding, materials and support to meet project goals and timelines.
- Previous budget and contract negotiation experience.
- Knowledge of GCP .
- Ability to pro-actively identify and solve problems that threaten timelines and successful completion of clinical trials.
- Able to work independently.
- Excellent time management skills (timelines, schedules, task prioritization).
- Willing and able to travel up to 30% of time.
The Clinical Research Associate manager role will support the Clinical Trial Manager/Operational Team in executing the trial(s) and maintaining effective communication with project teams to ensure alignment with study timelines.
The remote role will provide leadership, oversight and manage the activities of Clinical Research Associates (CRAs / Sr. CRAs) to ensure the delivery of all clinical studies to the agreed timelines, in compliance with Good Clinical Practice (GCP), company Standard Operating Procedures (SOP’s), and all applicable regulatory requirements.
- Responsible for line and performance management of CRAs / Sr. CRAs through regular individual one-on-one meetings, ensuring their understanding of protocols, timelines and all study related issues.
- Ensure effective delivery of study and business goals through identification and delivery of adequate training, coaching and mentoring of direct reports, including performance management.
- Responsible for review and approval of Trial Monitoring Plan (s) and Monitoring Visit Reports of direct report CRAs / Sr. CRAs within agreed timelines.
- Responsible for effectively managing capacity utilization CRAs / Sr. CRAs, ensuring alignment of capabilities with study requirements, resource availability and business priorities.
- Ensure that critical study timelines related to monitoring activities are achieved and that recruitment targets, patient recruitment cycle times, data and audit quality and site related milestones are met.
- Provide troubleshooting, problem resolution and co-monitoring support for CRAs / Sr. CRAs at sites to ensure productive, efficient study delivery.
- Maintain understanding and alignment of overall business priorities through close working partnerships with key stakeholders. Strategically assesses future requirements for resources and research sites.
- Work with CRAs / Sr. CRAs to set objectives for the year and review these with them at timely performance review meetings. Provide feedback to CRAs / Sr. CRAs regarding their performance and development. Ensure appropriate and timely escalation of issues to Clinical Trial Manager and other key stakeholders as appropriate.
- Ensure conduct of all clinical studies is in accordance with GCP’s, International Harmonization Guideline, and company SOPs
- Effectively support CRAs / Sr. CRAs with site management and co-monitoring activities – evaluate, initiate, monitor, and close tasks associated with the management of clinical sites
- Assists with audits/inspections of local clinical operations department & study / sites in the country.
- Responsible to acquire and maintain therapeutic and product specific knowledge across the relevant parts of the Enterin portfolio. Participate continuously in relevant training courses to improve personal/professional skills.
- Keep up to date with all the changes / required knowledge on ICH GCP, Enterin SOPs and attending appropriate training sessions. Serve as an expert in ICH GCP and Enterin SOPs for internal and insourced CRAs / Sr. CRAs.
- Serve as primary contact for CROs/vendors, Investigators, and study coordinators for study related questions
- Collaborate with study team to support feasibility and site selection process for clinical studies
- Develop and maintain study-related clinical documents and tracking tools to support management of clinical studies
- Review all AE/SAEs and ensure appropriate documentation is recorded and safety issues are addressed and communicated
- Assist and support data validation and data cleaning procedures to meet timelines
- Plan and participate in Investigator meetings and CRA trainings
- Minimum of 10 years of experience in the pharmaceutical / biotechnology industry monitoring as a Clinical Research Associate from study start-up to database lock required
- Minimum of 2 years of experience in CNS monitoring Phase 1-3 pharmaceutical/ biotechnology clinical trials preferred>
- Experience with line management of CRAs / Sr. CRAs
- Detailed understanding of ICH guidelines, GCP’s, PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, and other relevant, local regulatory requirements
- Good knowledge of concepts of clinical research and drug development
- Strong working knowledge of EDC, IVR and CTMS systems
- Ability to travel 40-60%
- Minimum of bachelor’s degree with strong emphasis on science required
To be a best-fit, your strengths must include:
- Strong Leader. You will need to use decision-making skills in order to ensure professional deliverables are being met.
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You will need excellent people management skills to mentor and coach others and establish and nurture highly effective relationships in order to key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
- Strong computer skills
- Flexible with high learning agility
- Acts as role model in line with company core values and behaviors
- Create and/or support new ways of working
- Strong written and verbal communication skills in English and local language (if applicable), good presentation, negotiation and influencing skills.
- Reliability and punctuality (high level of professionalism)
- Recognizes potential obstacles and works to resolve them within set timelines, takes responsibility for own actions.
- Creative, logical and strategic thinker
- Proactive, conscientious and precise in delivery of quality work even when under pressure.
- Effective at analyzing and escalating issues, solving problems and resolving conflicts.
- Good project management skills
- Effective time management skills.
- Good interpersonal skills.
- Strong planning & organizational skills, and the ability to work efficiently and effectively in a dynamic environment.