General Manager - Clinical Operations - Healthcare

Job Description

Position - GM - Clinical Operations - CRO Clinical Research

Job Location :- Miyapur Road - Hyderabad, Telangana

Interview Process:-

If your candidature is shortlisted based on your CV then there will be 2 Rounds :- 1st Round Telephonic & 2nd Round Skype.

Kindly provide the below details. I will call you & disclose client name before sharing your profile with the client:-

Current Company-
Previous Company-
Total Exp -
Relevant Exp in CRO (Clinical Research Organisation) -
Exp in Clinical Operations-
Current Location-
Ready to work in Miyapur, Hyderabad -
Current Salary -
Expected Salary -
Notice Period -
Earliest Joining Time -
Any active offers in hand (Yes/No)-
Reason for Job Change -
Do you have any active offers in hand, if yes what is the package offered to you & what is your LWD & DOJ the new company -
Essential Function:

- Provide overall leadership in project execution entrusted to your verticals

- Develop, as necessary, and ensure compliance with the company's SOPs and relevant regulations

- Provide overall direction in the areas of project tracking/ management, personnel management and training, revenue recognition, proposal development/ management, pricing, and participate in client meetings and presentations

Relationships:

Reports to: Associate Vice President

- Works closely with: Operation Team, Business Development, Project Team, Data Managers, Quality Assurance, Business Operations, Finance Manager

- External relationships: Consultants, Subcontractors, Partners

Responsibilities:

- Oversee and coordinate all project deliverables

- Serve as primary point of contact between all verticals and divisions to ensure that project-specific technical needs are met

- Participate in strategic planning for new and existing products/services

- Track project budgets and timelines

- Oversee resourcing of all active projects entrusted with responsibility for hiring and firing

- Coordinate appropriate training activities for staff members

- Responsible for revenue recognition and forecasting on a monthly basis

- Hold regular meetings with, project managers and, as necessary, project teams to monitor project progress, assure that individual project plans are updated, and assure that out-of-scope situations are identified and addressed

- Establish standard processes for product/service delivery

- Develop, as necessary, and ensure compliance with relevant standard operating procedures

- Responsible for quality and regulatory compliance of deliverables working closely with Quality Management staff

Skills :

- Excellent interpersonal and relationship building, verbal and written communication skills including excellent presentation skills

- Team player with outstanding negotiation and organizational skills

- Client focused approach to work

- A flexible attitude with respect to work assignments, new learning and travel

- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail

- Willingness to work with multiple colleagues and to value the importance of team work

- IT literate (experience with Microsoft based applications and general knowledge of PC functions)

- Able to take initiative and work independently

- Success in leading new business initiatives and managing the P&L of a company, division, or department

Education:

- Educated to Masters/ Doctorate degree level (biological/ life science, pharmacy or other health related discipline preferred) or equivalent medical qualification/

Experience:

- Education in Clinical Research is highly desirable

Language Skills:

- Competent in written and oral English

Minimum Relevant Work Experience:

- At least 10 -12 years work experience in either a pharmaceutical, CRO, medical device or clinical development capacity including significant previous management experience.

- Technical background is highly desirable

- Working knowledge of the drug development process is highly desirable

Physical Requirements:

- Ability to travel for 15 -20 days in a month.

Industry :- Pharmaceuticals

Location :- Hyderabad, Telangana

About us

The company is one of the most experienced and fastest growing Clinical Research Organization.

Our state-of-the-art facilities houses 500+ dedicated full-time professionals to ensure the quick turn around time with high quality. Our facilities are accredited by DCGI (Drugs Controller General India), NABL (National Accreditation Board for Testing and Calibration Laboratories - ISO 15189:2003) and inspected by US-FDA, UK-MHRA, Brazil-ANVISA, France AFSSAPS / ANSM, GCC, MCC-South Africa etc.

Within short span, we have achieved the milestone of completing 2750+ clinical studies and 1000+ product approvals from various regulatory agencies.

65+ regulatory audits from global competent authorities is testament to our professionalism and dedication to quality studies.

Our Phase II IV capabilities are growing along with an extended portfolio of Site Management, Medical Writing, and Data Management.

Industries:- Pharmaceuticals

Company size:- 201-500 employees

Headquarters:- Hyderabad, Telangana

Type:- Privately Held

Founded:- 2004

Specialties :- Clinical Trials, BA/BE studies, Special / Patient Population (PK/PD) studies, Clinical Data Management, Phase II - IV Trials, Bioequivalence / Bioavailability studies, Clinical Assay, Clinical Reference Laboratory services, Bioanalysis, and Medical Writing

Locations :-Primary

Miyapur Road

Hyderabad, Telangana, IN

Calle Ing.Basiliso Romo Anguiano 225.

Col. Guadalupe Insurgentes.

M- xico D.F., MX

About The Company:-

Our DNA

Our client is an efficient, metric based clinical research provider with a global footprint of operations. Our mandate recognizes the need within the medical research community for quality clinical services backed by experience, ICH/GCP training, protocol adherence, and leadership at significant cost advantages. Representing a vertically integrated CRO, we provide a collaborative and personalized approach to meet sponsor study requirements.

Offering trial management and monitoring, quality assurance, regulatory submissions, data management and biostatistics, makes us the assembly of a functional team ideally suited for clinical study. Our clients have ranged from big pharma majors to the emerging biotechnology sector. Our customized billing models help us add new clients along with the retention of our recurring clientele.

With over 2,500 studies for various regulated markets, a huge data bank of validated bio-analytical methods for over 350 molecules and the facilities being inspected and approved by various global regulatory authorities, the company ranks among the Top Clinical Research Organizations in India. As a Clinical Research Organization, our core competencies are in the realm of planning, designing and managing Clinical Trials - with clients that include national and international Pharmaceutical majors (innovators as well as generic pharmaceutical enterprises), Biotechnology and Medical Device organizations. Our clinical research programs employ the latest study designs in clinical pharmacology, Bio-Analytical method development and Pharmacokinetic analysis, conducted by a team of experienced and well-trained clinical coordinators and research associates.

The company's objective - A Promise to Precision in Clinical Research

Fact sheet

2,600+ clinical studies completed since inception

350+ bioanalytical methods developed

50+ successful Regulatory audits

Global footprint of operations with sites in India, U.S & Mexico.

Two clinical facilities (Hyderabad & Ahmedabad) in India

100+ National and International Pharma/Biotech Sponsor companies working with our client

US FDA : 500+ approvals, EMEA : 100+ approvals, Canada : 50+ approvals, Australia : 50+ approvals

500+ experienced employees working globally

Huge database of patient population in various therapeutic areas viz. Cardiology, Opthalmology, Schizophrenia, Diabetology, Oncology. Orthopedics etc..